Orphee Mythic 22-AL Hematology Analyzer - User Manual

REF : M22AL/UM/EN/004 REVISIONS Revision Nb 01 02 03 04 Date 28/05/10 25/06/10 04/08/10 13/08/10 Author HC HC HC HC Software > V0.4.0 > V0.5.0 > 1.0 > 1.0 Comments Creation. Update of the entire document. Update of the sections 3.4.3/3.4.1/3.4.4/5.10.1/7.2 Add the Declaration of Conformity CONTACT ADDRESS MANUFACTURER M LOCAL AGENT ORPHEE SA 19, chemin du champ des filles CH-1228 Plan-les-Ouates SWITZERLAND Tel : +41 22 884 90 90 Fax : +41 22 884 90 99 http://www.orphee-medical.com MYTHIC 22 AL Copyright© Orphee SA. All Rights Reserved. Page 1/109 REF : M22AL/UM/EN/004 WARNING Important Safety Instructions Must be read before attempting to install the product. CAUTION - RISK OF DANGER Indicates a procedure to be strictly respected in order to avoid any risks for the operator (user) or damages on the instrument or on the quality of results. CAUTION – BIOHAZARD RISK Indicates that wearing gloves is mandatory before performing the described operation due to risk of contact with materials that may be infectious. CAUTION – HOT SURFACE Indicates hot temperatures surfaces and risk of burns CAUTION – CLASS 2 LASER RADIATION Indicates laser radiation and do not stare into the beam NOTA Indicates important additional information The slots and openings in the back or bottom are provided for necessary ventilation. To ensure reliable operation of this apparatus or its DC adaptor, and to protect it from overheating, these openings must never be blocked or covered. Do not place this apparatus or its DC adaptor near or over a radiator or heat resistor, or where it is exposed to direct sunlight. Do not place a vessel containing liquid on this apparatus and its DC adaptor, as this can result in a risk of fire or electric shock. Do not expose this apparatus or its DC adaptor to rain or place it near water. If this apparatus or its DC adapter accidentally gets wet, unplug it and contact your service center immediately. Make sure to pull out the power cord from the outlet before cleaning. Do not overload wall outlets, extension cords or adaptors beyond their capacity, since this can result in fire or electric shock. Do not use travel power adapter Power-supply cords should be routed so that they are not likely to be walked on or pinched by items placed upon or against them. Page 2/109 Copyright© Orphee SA. All Rights Reserved. MYTHIC 22 AL If this apparatus does not operate normally – in particular. high or low temperatures. make sure the voltage designation of the DC adaptor corresponds to the local electrical supply.  Only the reagents mentioned in this manual are permitted to be used. Use adequate protection to prevent any risk of contamination (gloves. make sure to hold the power plug when pulling the plug from the outlet. All Rights Reserved. Use only a properly grounded plug and receptacle. Failure to do so may cause serious damage to your set. never touch the inside of the DC adaptor. unplug it from the wall outlet.  The optimum performances can be only achieved if the cleaning and maintenance procedures are carefully followed. when installing your set in a location with heavy dust. Never insert anything metallic into the open parts of the DC adaptor.  Only human blood or artificial control blood should be run.REF : M22AL/UM/EN/004 To protect apparatus or its DC adaptor from a lightning storm. To avoid electric shock. An improper ground may cause electric shock or equipment damage. MYTHIC 22 AL Copyright© Orphee SA. Always replace or use parts of the apparatus supplied by your service center. Doing so many create a danger of electric shock. high humidity or chemical substances. The MYTHIC 22 AL is an automated hematology analyzer for in vitro diagnostic to be used in clinical laboratories by an authorized people. disconnect the power cord and contact your service center. When removing the power cord. if there are any unusual sounds or smells coming from it – unplug it immediately and contact your service center. therefore the mains plug shall be readily operable. Before connecting the AC power cord to the DC adaptor outlet. glasses. the plug must be pulled out from the mains socket. This will prevent damage to the set due to lightning and power line surges. Page 3/109 . Be sure to contact an authorized service center. The elimination of waste supplied by this apparatus must be done in compliance with your local authorities. disinfectant). If the product is damaged. Do not drop or impart any shock to the product. To disconnect the apparatus from the mains. Do not install the product in an unstable location such as a shaky table or a location exposed to vibration. or when it is left unused for long periods of time. Make sure to plug the power cord in until it is firmly inserted. Do not touch the power cord or DC adaptor with wet hands. All parts or surfaces of this apparatus could be potentially infective. Do not stare into the beam All operations of service must be do after equipment is switched off. By removing the protect cover operator could have exposure to hazardous laser radiation. All Rights Reserved.REF : M22AL/UM/EN/004 ATTENTION RAYONNEMENT LASER DE CLASSE 2 EN CAS D’OUVERTURE NE PAS REGARDER DANS LE FAISCEAU CAUTION CLASS 2 LASER RADIATION WHEN OPEN DO NOT STARE INTO THE BEAM This equipment has an embedded class 2 laser product. Wavelength: 650nm Beam divergence: 54° Pulse duration and repetition rate: 200 scans/s Maximum power: 1mW Page 4/109 Copyright© Orphee SA. MYTHIC 22 AL . Immunity test Electrostatic discharge (ESD) IEC 61000-4-2 IEC 60601 test level ±6 kV contact ±8 kV air Compliance level Complies Electromagnetic environment . Complies Power frequency (50/60 Hz) magnetic field IEC 61000-4-8 Complies Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.REF : M22AL/UM/EN/004 This equipment needs special precautions regarding general requirements for safety. All Rights Reserved. Mains power quality should be that of a typical commercial or hospital environment. Guidance and manufacturer’s declaration – Electromagnetic emissions The MYTHIC 22 AL is intended for use in the electromagnetic environment specified below. including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.guidance Floors should be wood. Harmonic emissions Emissions test Compliance level Class A IEC 61000-3-2 Voltage fluctuations/flicker emissions IEC 61000-3-3 Complies The MYTHIC 22 AL is suitable for use in all establishments. If floors are covered with synthetic material.guidance Guidance and manufacturer’s declaration – Electromagnetic immunity The MYTHIC 22 AL is intended for use in the electromagnetic environment specified below. it is recommended that the MYTHIC 22 AL be powered from an uninterruptible power supply or a battery. the relative humidity should be at least 30 %. Electromagnetic environment . Page 5/109 .5 cycle 40 % UT (60 % dip in UT) for 5 cycles 70 % UT (30 % dip in UT) for 25 cycles <5 % UT (>95 % dip in UT) for 5 sec 3 A/m Complies Mains power quality should be that of a typical commercial or hospital environment. The customer or the user of the MYTHIC 22 AL should assure that it is used in such an environment. MYTHIC 22 AL Copyright© Orphee SA. The customer or the user of the MYTHIC 22 AL should assure that it is used in such an environment. Electrical fast transient/burst IEC 61000-4-4 Surge IEC 61000-4-5 Voltage dips. short interruptions and voltage variations on power supply input lines IEC 61000-4-11 ±2 kV for power supply lines ±1 kV for input/output lines Complies Mains power quality should be that of a typical commercial or hospital environment. mains voltage prior to application of the test level. NOTE UT is the a. If the user of the MYTHIC 22 AL requires continued operation during power mains interruptions.c. concrete or ceramic tile. ±1 kV differential mode ±2 kV common mode <5 % UT (>95 % dip in UT) for 0. field strengths should be less than 3V/m.2√P 3 Vrms d = 1. the MYTHIC 22 AL should be observed to verify normal operation. additional measures may be necessary. such as reorienting or relocating the MYTHIC 22 AL.5Ghz 3 Vrms d = 1. Field strengths from fixed RF transmitters. the higher frequency range applies. Immunity test IEC 60601 test level Compliance level Electromagnetic environment . b Over the frequency range 150KHz to 80MHz. such as base stations for radio (cellular/cordless) telephones and land mobile radios. If abnormal performance is observed. a Field strengths from fixed transmitters. AM an FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy.5GHz Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Page 6/109 Copyright© Orphee SA. MYTHIC 22 AL . To assess the electromagnetic environment due to fixed RF transmitters. as determined by an electromagnetic site survey. All Rights Reserved. Electromagnetic propagation is affected by absorption and reflection from structures.a should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol: NOTE 1 At 80Mhz and 800MHz. including cables. The customer or the user of the MYTHIC 22 AL should assure that it is used in such an environment. objects and people. amateur radio. If the measured field strength in the location in which the MYTHIC 22 AL is used exceeds the applicable RF compliance level above.2√P 80MHz to 800MHz d = 2. Recommended separation distance Conducted RF IEC 61000-4-6 Radiated RF IEC 61000-4-3 3 Vrms 150Khz to 80Mhz 3 Vrms 80Mhz to 2.guidance Portable and mobile RF communications equipment should be used no closer to any part of the MYTHIC 22 AL.3√P 800MHz to 2.REF : M22AL/UM/EN/004 Guidance and manufacturer’s declaration – Electromagnetic immunity The MYTHIC 22 AL is intended for use in the electromagnetic environment specified below. than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. an electromagnetic site survey should considered. NOTE 2 Theses guidelines may not apply in all situations. . This equipment generates uses and can radiate radio frequency energy and. which can be determined by turning the equipment off and on.REF : M22AL/UM/EN/004 NOTE: This equipment has been tested and found to comply with the limits for a Class B digital device. 20402. there is no guarantee that interference will not occur in a particular installation. the user is encouraged to try to correct the interference by one or more of the following measures: .C. prepared by the Federal Communications Commission. helpful: How to identify and Resolve Radio/TV Interference Problems. may cause harmful interference to radio communications. Washington. . By ensuring this product is disposed of correctly. if not installed and used in accordance with the instructions.Consult the dealer or an experienced radio/TV technician for help.Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. Instead it shall be handed over the applicable collection point for the recycling of electrical and electronic equipment.Increase the separation between the equipment and receiver. For more detailed information about recycling of this product. D. However. The user may find the following booklet. All Rights Reserved. pursuant to Part 15 of the FCC Rules. please contact your local city office or your distributor of this product. . Stock No. The symbol on the product indicates that this product may not be treated as household waste. any changes or modifications to this equipment not expressly approved by C2 Diagnostics may cause.S. Pursuant to Part 15. 004-000-00345-4. These limits are designed to provide reasonable protection against harmful interference in a residential installation. Page 7/109 . you will help prevent potential negative consequences for the environment and human health. If this equipment does cause harmful interference to radio or television reception.Reorient or relocate the receiving antenna.21 of the FCC Rules. Government Printing Office. which could otherwise be caused by inappropriate waste handling of this product. MYTHIC 22 AL Copyright© Orphee SA. This booklet is available from the U. harmful interference and void the FCC authorization to operate this equipment. meets all the provisions of the directive on in vitro diagnostic medical devices 98/79/EC which apply to it. annexe II / Dispositivo dell’elenco B. Anhang II / Dispositif de la liste A. allegato II / Device of List B. Page 8/109 Copyright© Orphee SA. soddisfa tutte le disposizioni della direttiva relativa ai dispositivi medico-diagnostici in vitro 98/79/CE che lo riguardano. die anwendbar sind. Annex II Produkt zur Eigenanwendung. remplit toutes les exigences de la directive relative aux dispositifs médicaux de diagnostic in vitro 98/79/CE qui le concernent.A. M22AL mit folgender Klassifizierung nach der Richtlinie über In-vitro-Diagnostika 98/79/EG avec la classification selon la directive relative aux dispositifs médicaux de diagnostic in vitro 98/79/CE con la classificazione secondo la direttiva relativa ai dispositivi medico-diagnostici in vitro 98/79/CE classified as follows according to the directive on in vitro diagnostic medical devices 98/79/EC Produkt der Liste A. MYTHIC 22 AL . Anhang II / Dispositif de la liste B. All Rights Reserved. Annex II Produkt der Liste B. das nicht in Anhang II genannt ist / Dispositif destiné à l’autodiagnostic non listé dans l’annexe II / Dispositivo per test autodiagnostico non elencato nell’allegato II / Device for self-testing not listed in Annex II Sonstiges Produkt / Autre dispositif / Altro dispostivo / Other device allen Anforderungen der Richtlinie über In-vitro-Diagnostika 98/79/EG entspricht. 19 Chemin du Champ des Filles 1228 Plan Les Ouates das Medizinprodukt für die In-vitro-Diagnostik le dispositif médical de diagnostic in vitro il dispositivo medico-diagnostico in vitro the in vitro diagnostic medical device Mythic 22 AL Ref.REF : M22AL/UM/EN/004 KONFORMITÄTSERKLÄRUNG / DECLARATION DE CONFORMITE DECLARATION OF CONFORMITY / DICHIARAZIONE DI CONFORMITA Name und Adresse der Firma Nom et adresse de l’entreprise Nome e indirizzo della ditta Name and address of the firm Wir erklären in alleiniger Verantwortung. annexe II / Dispositivo dell’elenco A. dass Nous déclarons sous notre propre responsabilité que Dichiariamo sotto nostra responsabilità che We declare under our sole responsibility that Orphée S. allegato II / Device of List A. REF : M22AL/UM/EN/004 Angewandte Gemeinsame Technische Spezifikationen, harmonisierte Normen, nationale Normen oder andere normative Dokumente Spécifications techniques communes, normes harmonisées, normes nationales et autres documents normatifs appliqués Specifiche tecniche comuni, norme armonizzate o nazionali applicate, altri documenti normativi applicati Applied common technical specifications, harmonised standards, national standards or other normative documents Konformitätsbewertungsverfahren Procédure d’évaluation de la conformité Procedimentodi valutazionedellaconformità Conformity assessment procedure Konformitätsbewertungsstelle (falls beigezogen) Organe respons. de l'évaluat.de la conformité(si consulté) Organo incaric. della valutaz. della conform. (se consultato) Notified Body (if consulted) Ort, Datum / Lieu, date / Luogo, data / Place, date Geneva, 10.08.2010 IEC IEC IEC IEC IEC 60825-1:2007 61010-1:2001 61010-2-101:2002 61010-2-081:2001 and A1:2003 61326-2-6:2005 Annex III N/A Name und Funktion / Nom et fonction /Nome e funzione / Name and function Tomasz Tuora CEO & President MYTHIC 22 AL Copyright© Orphee SA. All Rights Reserved. Page 9/109 REF : M22AL/UM/EN/004 Page 10/109 Copyright© Orphee SA. All Rights Reserved. MYTHIC 22 AL REF : M22AL/UM/EN/004 TABLE OF CONTENTS 1. INSTALLATION ..................................................................................................... 14 1.1 UNPACKING .................................................................................................................................................................................................. 14 1.1.1 1.1.2 1.1.3 Introduction ................................................................................................................................................................................................. 14 Unpacking Procedure ................................................................................................................................................................................... 14 Visual checking ............................................................................................................................................................................................. 15 Installation place ......................................................................................................................................................................................... 16 Installation environment ............................................................................................................................................................................ 16 Rear connectors ........................................................................................................................................................................................... 16 Front connectors ......................................................................................................................................................................................... 17 Power supply block ....................................................................................................................................................................................... 17 1.2 1.3 1.2.1 1.2.2 1.3.1 1.3.2 1.3.3 INSTALLATION CONSTRAINTS .................................................................................................................................................................. 16 ELECTRICAL CONNECTIONS ........................................................................................................................................................................ 16 1.4 1.5 1.5.1 1.5.2 PRINTER CONNECTION ................................................................................................................................................................................ 17 CONNECTION, CHANGE AND PRIMING REAGENTS .................................................................................................................................... 18 Connection ..................................................................................................................................................................................................... 18 Priming............................................................................................................................................................................................................ 19 2. 1.6 TRANSPORTATION AND STORAGE ............................................................................................................................................................. 21 GENERAL OVERVIEW ............................................................................................... 22 2.1 INTENDED USE ........................................................................................................................................................................................... 22 2.2 GENERALITIES ............................................................................................................................................................................................ 22 2.3 OVERVIEW ................................................................................................................................................................................................... 23 2.4 MAIN PART DESCRIPTION .......................................................................................................................................................................... 23 2.4.1 2.4.2 2.4.3 2.4.4 2.4.5 Display ............................................................................................................................................................................................................ 23 Dilution fluidic part ..................................................................................................................................................................................... 25 Power Supply Block ...................................................................................................................................................................................... 26 Reagent tray ................................................................................................................................................................................................. 27 Sampler .......................................................................................................................................................................................................... 27 3. INSTRUMENT SET UP .............................................................................................. 28 3.1 USER’S IDENTIFICATION.......................................................................................................................................................................... 28 3.2 SYSTEM STATUS......................................................................................................................................................................................... 29 3.3 SET UP ......................................................................................................................................................................................................... 29 3.4 ADVANCED SET-UP ..................................................................................................................................................................................... 30 3.4.1 3.4.1 3.4.2 3.4.3 3.4.1 3.4.1 3.4.2 3.4.3 3.4.4 3.1.1 3.1.2 Start Up Machine ........................................................................................................................................................................................ 28 In process ..................................................................................................................................................................................................... 28 Sampler option: ............................................................................................................................................................................................ 30 Analysis options: .......................................................................................................................................................................................... 30 Lab. parameters: .......................................................................................................................................................................................... 31 Other Setting: ............................................................................................................................................................................................. 34 Printer set up: .............................................................................................................................................................................................. 34 Communication: ............................................................................................................................................................................................. 35 Calibration factor: ....................................................................................................................................................................................... 36 Storage options:........................................................................................................................................................................................... 36 Version release:............................................................................................................................................................................................ 37 4. SPECIFICATIONS ................................................................................................... 38 4.1 ANALYTICAL SPECIFICATIONS ................................................................................................................................................................. 38 4.2 PHYSICAL SPECIFICATIONS ...................................................................................................................................................................... 40 4.3 REAGENTS SPECIFICATIONS .................................................................................................................................................................... 42 4.3.1 4.3.2 4.3.3 4.4.1 4.4.2 Diluent ............................................................................................................................................................................................................ 42 Lytic reagent “OnlyOne” ............................................................................................................................................................................ 43 Cleaning solution ........................................................................................................................................................................................... 44 Recommendations......................................................................................................................................................................................... 45 Interferences............................................................................................................................................................................................... 45 4.4 ANALYTICAL LIMITATIONS ...................................................................................................................................................................... 45 MYTHIC 22 AL Copyright© Orphee SA. All Rights Reserved. Page 11/109 ................................... 63 PCL6 model report ........................1 5.....................................................................................1 INTRODUCTION .................................. 55 Display run............................................................................2.......... 51 5................................................................................................................ 53 5......................................2 SWITCH ON .......................................................................................... 76 8.................................................................................7 8.............................................6........................5....... 83 Platelet Flags ............................................................................................................................................ 68 QUALITY CONTROL ..................................4 ANALYSIS OF PLATELETS ...........................................................................5............................ 6.............................. 69 6................................................................................................................................................................................. 52 Introduction ..............................................................................................................................................5 8....................................................2 8..................................................... 83 QC Flags ............................................................................................................................5............................................................................................................................................. 67 6...........................................................................................................6 8...............5 FLAGS ...........................................................................................3 REAGENT REPLACEMENT .........1 7.............2 View ............ 74 8..............................................6...2 5............................................................5.................................................................................................................................................................2 LEUKOCYTE ANALYSIS ................................................................................................................................................................................................................................................................................ SAMPLE ANALYSIS ..........................2 8................................................................8...........6.......................... 83 STARTUP Flags ..................... 80 8..............................................................................................................................................................................................................................................................................................1 6.................................................8 5...... 78 8.......4 START UP RINSING....................................... MYTHIC 22 AL ................................................................................................................................................................................................. 59 STAT or other vial sample run...... 81 Instrument Flags ...5..........................................................................1 8.............2 8.......................................................................................................................................................................................................................................................................................................................................................................................................................................................... 72 CALIBRATION ............................1 RUN CALIBRATOR ..................................................9 LOGS INTERVENTIONS ...........................................................................................................................................8.........................................................................................................................................................................6.........................................................2 Calibration blood analysis ................ 84 Syringes module ................................................................................................................................. 63 5..........................................................................................................................10 ARCHIVE ............................................ 74 Calibration .............. 84 Page 12/109 Copyright© Orphee SA......................................3 ERYTHROCYTE ANALYSIS ...................................................... PLT Counting...........................7 DISPLAY RUNS ...................................................1 Results ...........1 DETECTION PRINCIPLE .................................................. 52 Blood sample collection tube ..................................................................................................................6..................................... 70 Run control blood .........4 8.......5 PREPARATIONS BEFORE ANALYSIS ......REF : M22AL/UM/EN/004 5................................................................... 78 Local blood control limitations ...............................................................................................................................................................................................................................................................................................................6.................................................................................................................................................................................................................................................. 65 5............................................................... 84 8..........6.......................... 82 Erythrocyte and HGB Flags .... 66 5........... 64 5...........................................................................................................................2 5.............8 PRINTING ....................1 PCL3/LX 300 (USB) model report..5 5. RBC.................................................... 81 8..................2 TARGET VALUES MODIFICATIONS ...................................................................................................................................................................................................................................2....................................................................................... 79 8............ 77 Hemoglobin measurement .................................. All Rights Reserved............................... 84 Optical manifold ..................................1 8....................1........................................................................1 VERIFICATIONS BEFORE STARTING ........................................................................................................4 8............1........ 84 Counting bath module ........................................... 52 5................ 54 Modify an order ............... 76 Five part diff measurement ...........................................................................................6......................................................................6 5................................................ 50 5..................................................................................................6 HYDRAULIC & MECHANIC DESCRIPTION ...................................................2 5...............................................................................................................................................................................5.............................................................................................................................................................................1............................................................................................... 73 7...................................................................................................................................................... 74 7................................2 8........................................................................................................................................................................ 50 5..................................................................................................................................... 69 6................................................. 55 New Order ................3 5.................................6......................................................................................................... 69 6....................................................... 60 5....................... 71 7.........................6............................2..........6.........................1 5.......................................................3 7........................................................................................................ 78 Measurement ......................................................................................................................................................................................................................................................................9 Blood collection .............................................................6..........5........................................................................................................................ 61 5............................................... 50 5............................................................................. 81 8..............6............................. 83 Auto loader module.......................................6...... 53 Work list...................4 5...................... Change .....................................10................................................... 66 5............................... WBC...........3 8...1.................... 75 TECHNOLOGY ..............................................1 5.................................5 General Flags .....................................................................................................6 ANALYSIS .. 84 Sampling module ................................................................................................................................................................................. 76 8.1 8............... 50 5...........................................3 REPEATABILITY ..............................................................2.............................................................................5..................................................................................................................................................... 56 STAT or other vial Sample Identification ................................................................................................1 8.............................................................................................................................10.................1...............................................................................................................................7 5................................. 55 Run Rack......................................................................................................................................2 QUALITY CONTROL .................................................................................... 82 Leukocytes Flags .................................................................................................5................................3 8...........................................................................................11 STAND BY AND SHUT DOWN................................................................................................................................................................................................................................................ 53 Working rules ....................... ..............2 Optical bench..................................................5.....................................................................................................................................1 MAINTENANCE ..............................................................................................................................2 9................. 94 Log errors..........................................................................6 TROUBLESHOOTING MESSAGE .............................................................................................4..........................................REF : M22AL/UM/EN/004 8..................................................................................................................................................................................1 9..............5 9..................................................................2 Sampler .....................................................................................................................4 9.........5............................3 TROUBLESHOOTING SCREEN............. 93 Check valves .....................................................................................................................7 SOFTWARE .............7 HYDRAULIC DIAGRAM.............................................2 9...........................1....................7................................... 94 Needle or o-ring replacement ...................................................1................. 87 9.........................................3 9.............. 90 In line filter cleaning .......................................1 8.................................................................... 100 Aperture block replacement...........................................................3................2 9.................................................................................................................................................................................. 103 9.......................................................................... 87 Concentrate cleaning .................... All Rights Reserved. 87 9....................................................................................................................................................................................................... 91 Barcode cleaning ............................ 85 Common Functionalities ..............................................................5 9..........................................................................................................................................................1 9.........................................................................................................5 TROUBLESHOOTING OCCURENCES......................................................... 102 Other problems .......................5 Maintenance table ............................................................4 9.........1.................................................................................................108 MYTHIC 22 AL Copyright© Orphee SA............................................................................................................................................... 86 8.................................6 8....................................................................................................................................................................... 94 Emergency stop ........................................................................................ 93 Check motors fluidics ..........................................................................................................................................................................................................................................................................................................................1...3 9...............................................3 9.....................................4.............. Page 13/109 ........................ 93 Check sensors .......................................................... 85 9... 98 Baths o-ring replacement ......................................................4.......................................3........................................................................................................................................................................................... 101 Analytical problems ........... 95 Baths dismantling........................................2 CLEANING CYCLES...........................................4 9.........6.........................................................3..............................................................4................................. 92 9....................... 94 9....................................................102 9.............................................. 88 Piston greasing ................................................. 91 9............................................................................................................................................................................................................................................................................................................... SERVICE ........................................................1 9............................................................................................................................................1 9................................................... 85 Menu tree ...............................................................................................................................1......................4 REPAIRING .......... 92 9....................7..................3.....................3........................................................105 9.........4.................................................................................................................................................................................... 1. INSTALLATION 1.1. Remove the MYTHIC 22 AL from the box.1 Introduction The MYTHIC 22 AL is an automated hematology analyzer for in vitro diagnostic use in clinical laboratories by an authorized and trained people. If the MYTHIC 22 AL has been stored at a temperature lower than 10°C it must be left at room temperature during 24 hours before power on.1 UNPACKING 1. MYTHIC 22 AL .WASTE 150W DC adaptor European Power line cord MYTHIC 22 AL User’s manual Screwdriver Slot 1/4" QTY 1 10 5 2 1 1 1 Tubing 50 Silicon Sleeve Tie wraps Rinsing Head O-ring Silicon grease (3gr) Short Arm TORX T10 Tool Short Arm TORX T20 Tool MAINTENANCE KIT Designation 10 Racks Page 14/109 Copyright© Orphee SA. 1. INSTALLATION REF : M22AL/UM/EN/004 1. remove the starter kit.The optimum performances can only be achieved if the cleaning and maintenance procedures are carefully followed (see section 9. we recommend to check the box of the instrument and notify any damage to the carrier. Starter kit contents: INSTALLATION KIT QTY 1 1 1 1 1 1 Designation Tubing 23 .1. Open the box on the top.Only human blood or artificial blood (recommended control or calibrator) should be run. . . All Rights Reserved.DILUENT Tubing 24 .Only the reagents mentioned in this manual are permitted to be used.1). .2 Unpacking Procedure Before unpacking the instrument. 3. BEWARE TO STAY AWAY FROM THESE PARTS WHEN THE MACHINE IS SWITCHED ON. 2.Rocker in front position at the maximum course. NEVER DISMANTLE THE COVER. To be checked: 1.Unscrew the two quarter turn screws with the key provided in the kit. .To remove the unloading table. THE BARCODE READER IS A LASER CLASS II. 1 2 HAZARDOUS MOVING PARTS. Page 15/109 . MYTHIC 22 AL Copyright© Orphee SA.1. then lift it to remove. push to the back first then lift it. INSTALLATION 1.Counting chambers perfectly locked in their manifold locations. All Rights Reserved. IN CASE OF PROBLEM CALL ORPHEE REPRESENTATIVE. .3 Visual checking . 3 Remove the plastic wedge of the bath block.Check the good fixation of the air pump.Needle’s dismountable system located in the rocker. .Open completely the door. .REF : M22AL/UM/EN/004 1.Open the door on the right side by unscrewing the two quarter turn screws with the key provided in the kit. 1. INSTALLATION 1.2 INSTALLATION CONSTRAINTS 1.2.1 Installation place REF : M22AL/UM/EN/004 To ensure that the MYTHIC 22 AL fulfills its function, place the instrument on a table which supports the weight of the instrument, printer and reagents (~40 Kg). Leave a space of 10 cm at the rear of the instrument to ensure a wellventilated place. Avoid a place that can be exposed to direct sunlight. 1.2.2 Installation environment a) Indoor use; b) Altitude up to 3 000 m (see NOTA hereafter); c) Temperature 18 °C to 34 °C; d) Maximum relative humidity 80 % for temperatures up to 31 °C decreasing linearly to 50 % relative humidity at 40 °C; e) MAIN supply voltage fluctuations up to ±10 % of the nominal voltage; f) Transient over voltages typically present on the MAIN supply. g) Rated pollution degree II. NOTA Please contact Orphee’s representative if you want to use the instrument in special conditions (altitude higher than 2000 m or special power supply conditions). 1.3 ELECTRICAL CONNECTIONS 1.3.1 Rear connectors CONNECTION : SYMBOL : - Not available - 1 USB port: This USB port can be used ONLY for the printer connection. - Ethernet connection (TCP/IP): - Host connection (RS232C): - External barcode reader (RS232C): - Equipotentiality: - Power supply cord connection: Page 16/109 Copyright© Orphee SA. All Rights Reserved. MYTHIC 22 AL REF : M22AL/UM/EN/004 1. INSTALLATION 1.3.2 Front connectors 3 USB ports Any output or input connections (except the printer and the barcode reader supplied by ORPHEE) cannot be done without the ORPHEE’s representative authorization. 1.3.3 Power supply block MYTHIC 22 AL must be connected to the power with the power supply block provided with the starter kit. Choose a well-ventilated place for the block and be sure to connect this power supply in a socket-outlet with a correct earth connection. The power supply block must be placed at the rear of the MYTHIC 22 AL and, if possible, in an upper position to avoid the contact with any liquid. To disconnect electrically the MYTHIC 22 AL, remove the power supply plug from the main circuit. In case of replacement of the main power wire, supplied with the MYTHIC 22 AL, the new one must comply with the local regulation (31.5mm cable and 250V 10A plug). The MYTHIC 22 AL has been certified with the power supply provided with the instrument. If another power supply is used with the instrument, Orphee or its representative will not apply any warranty on this power supply and on the instrument. Please contact Orphee or its local representative before using such material. 1.4 PRINTER CONNECTION ) of the MYTHIC 22 AL to connect the printer cable. Select the printer driver Connect the printer cable in conformity with the printer user’s manual. Use ONLY the rear USB plug ( (section 3.3). MYTHIC 22 AL Copyright© Orphee SA. All Rights Reserved. Page 17/109 1. INSTALLATION 1.5 CONNECTION, CHANGE AND PRIMING REAGENTS REF : M22AL/UM/EN/004 MYTHIC 22 AL works exclusively with the reagents described in section 4.3. Orphee or its local representative will not be responsible for the quality of the results and for the maintenance of the instrument if other commercial reagents are used. 1.5.1 Connection Lytic reagent and cleaning solution: Before handling the reagents, read carefully their specifications described in section 4.3 and check if their shelf life dates are not reached. - Remove the door on the left side of the instrument. - Put the reagent bottles into the dedicated location. - Remove the caps of the bottles. - Tighten the red caps on the OnlyOne bottle (red sticker) and the blue one on the cleaning solution bottle (blue sticker). Diluent and waste: - Connect the diluent tube (male connector) on the outlet on the bottom and tighten the cap on the diluent container. - To use 20 liters diluent container, add the tubing straw adaptor supplied with the installation kit. - Connect the waste tube (female connector) on the outlet on the top and tighten the cap on an empty container.  Do not modify the type and the length of the diluent and waste tubes.  The diluent must be placed at the same level as the MYTHIC 22 AL. Diluent Waste It is mandatory to collect the waste in a container and to treat it in compliance with your local regulations. Page 18/109 Copyright© Orphee SA. All Rights Reserved. MYTHIC 22 AL 2 Priming When using the MYTHIC 22 AL for the first time.To validate or not the modification. Before starting. .1).Connect the power supply block (see section 2. INSTALLATION 1. Page 19/109 . The reagents must be stored 24 hours minimum at room temperature before use. MYTHIC 22 AL Copyright© Orphee SA. be sure that all the reagent and waste tubes are properly connected. . the password (see section 3.Press the ON/OFF button. All Rights Reserved.The logo Orphee appears during a few seconds.7. see section 8.5.REF : M22AL/UM/EN/004 1. Priming procedure:  Switch on: . This operation should be done by a Field Service Engineer. .4). it is necessary to perform a complete prime of the fluidic circuit.The operator’s identification display appears. . .3.AUTONOMY (run) indicates the number of samples (runs) you can perform (calculated with the smaller volume of reagents).Enter the user’s identification.1.  Login: . To prime or to know the quantity of reagent. press the dedicated button.Press cycle counters.To reset the counter with the button .Press AL performs a complete priming cycle. Page 20/109 Copyright© Orphee SA. All Rights Reserved. . : The MYTHIC 22 .Press on .AUTONOMY (run) indicates the number of samples (runs).The main menu is displayed.1. REF : M22AL/UM/EN/004 NOTA To do an emergency stop in case of problem push briefly on the on/off button . please contact your Orphee’s representative. . INSTALLATION  System priming: . MYTHIC 22 AL . . to display the . it must be left at room temperature during 24 hours. LYSE AND CLEANER PRIME: Proceed as described above for the diluent. .7. enter the container volume in milliliter. perform a complete cleaning with a disinfectant in compliance with the local regulations.1.To validate or not the modification. see section 8. Storage temperature: -10°C to +50°C.9) .To validate or not the modification. the expiry date and the container capacity. press calculation.7. . MYTHIC 22 AL IS NOW READY TO OPERATE. All Rights Reserved.6 TRANSPORTATION AND STORAGE Before transportation outside the laboratory. see section 8.Enter lot number. Page 21/109 .Only enter the capacity of the container.From the MAIN MENU. to initialize the waste .1. . press then to have access to this screen.After replacement of the waste container. press . MYTHIC 22 AL Copyright© Orphee SA. .After the replacement of a new container or to prime the diluent. .If needed. INSTALLATION DILUENT PRIME: . If the MYTHIC 22 AL has been stored at a temperature lower than 10°C. 1. WASTE: .A new entry is automatically done in the logs (see section 5.Press to validate the new entry or after changing a new container with the same information.REF : M22AL/UM/EN/004 1. GENERAL OVERVIEW 2. .opened other vial in a special position (front door open) Throughput: close tube mode: > 40 samples/hour Other vial mode: > 45 samples/hour 22 analysis parameters in DIF mode and 12 parameters in CBC mode: Leukocyte parameters: WBC White Blood Cells LYM Lymphocytes in % & # (DIF mode only) MON Monocytes in % & # (DIF mode only) NEU Neutrophils in % & # (DIF mode only) EOS Eosinophils in % & # (DIF mode only) BAS Basophils in % & # (DIF mode only) Erythrocyte parameters RBC Red Blood Cells HGB Hemoglobin HCT Hematocrit MCV Mean Corpuscular Volume MCH Mean Corpuscular Hemoglobin MCHC Mean Corpuscular Hemoglobin Concentration RDW Red Blood cells Distribution Width Thrombocyte parameters PLT Platelet MPV Mean Platelet Volume PDW* Platelet Distribution Width PCT* Thrombocrit * For Investigation Use only in the United States of America Page 22/109 Copyright© Orphee SA. the total volume could be upper according to the blood remaining outside of the needle). GENERAL OVERVIEW 2. Two sampling modes: .2. .closed tube in 10 racks of 5 tubes .Only the reagents mentioned in this manual are permitted to be used.Only human blood or artificial blood (recommended control or calibrator) should be run.2 GENERALITIES MYTHIC 22 AL is a fully automated analyzer performing hematological analysis on whole blood collected on EDTA K2 or K3 tubes.1 INTENDED USE REF : M22AL/UM/EN/004 The MYTHIC 22 AL is an automated hematology analyzer for in vitro diagnostic use in clinical laboratories by an authorized and trained people. .The optimum performances can be only achieved if the cleaning and maintenance procedures are carefully followed (see section 9.2 µl (inside the needle. Sampling volume: 18. All Rights Reserved. 2. MYTHIC 22 AL .1). 4. Mono electronic board.3 OVERVIEW MYTHIC 22 AL consists of 9 main parts: 1. MYTHIC 22 AL Copyright© Orphee SA. 3. 5. Reagent tray.REF : M22AL/UM/EN/004 2. Auto loader system 2. 7. 2. Dilution hydraulic part.1 Display Use only a soft paper to clean the screen. All Rights Reserved. 6.4 MAIN PART DESCRIPTION 2. 9. never use direct liquid otherwise the screen could be damaged. External power supply block. 4. 8. Connection. Page 23/109 . GENERAL OVERVIEW 2. Barcode reader (option). Display. Printer. Mythic Parameters (Section 3). GENERAL OVERVIEW Main Menu description REF : M22AL/UM/EN/004 Back to previous screen Start Up rinsing and blank control (Section 5. Select Options Direct access to main menu Display of the sampler status Date and Time.11) Work list management and Analysis performing (section 5.1) Cleaning and standby mode (section 5.2.3). System status (Section 3.9). Reagent replacement (section 5.10) Page 24/109 Copyright© Orphee SA. Full screen run displayed (Section 3. System init (Section 9. All Rights Reserved. MYTHIC 22 AL . Log In and Log Out (section 3. Quality Control (Section 6). Patient Archive (Section 5.2).1).1) Calibration (Section 7).4.2) Print.5). Send. Maintenance and Service Menu Mythic Events Logs (Section 5. o Liquid valve manifold assembly and tubing.4. GENERAL OVERVIEW 2. Syringe module (patented) consists of one block : o Reagent syringes (Diluent.REF : M22AL/UM/EN/004 2. Optical bench : o Optical bench (patented) with its flow cell (patented). o Liquid valve manifold assembly and tubing.2 Dilution fluidic part All the fluidic part is on the right side of the instrument and consists of five modules only: Sampling module : o Rocker (patented) : Manages the rise and descent of the needle. Page 25/109 . Optical Manifold : o Liquid valve manifold assembly and tubing. Optical bench Optical manifold Sampling module Syringe module Counting module MYTHIC 22 AL Copyright© Orphee SA. lysis). Counting chambers : o WBC and RBC counting chambers and hemoglobin measurement. sampling and air syringes. All Rights Reserved. The board. MYTHIC 22 AL . Orphee or its representative will not apply any warranty on this power supply and on the instrument. rocker.If another power supply is used with the instrument. the new one must be in compliance with the local regulations.The MYTHIC 22 AL has been certified with the power supply box provided with the machine. Please contact Orphee or its local representative before using such material. Display and keyboard. Measurement (Optical and resistive counting. All Rights Reserved. syringe block motors. manages the following parts: Fluidics: sample needle.3 Power Supply Block MYTHIC 22 AL is supplied with an external power supply block. only the field service engineer may touch this electronic board. mixing and unloading. transfer. hemoglobin measurement). External barcode reader. . Printer. Data processing. . Autoloader: loading.2. To avoid all deterioration risks. GENERAL OVERVIEW Mono electronic board REF : M22AL/UM/EN/004 The mono electronic board is located between the hydraulic part and the reagent tray.4. Page 26/109 Copyright© Orphee SA. Ethernet …). Connection mode (RS232. 2. driven by a 32-bit processor. .In case of replacement of the main power wire supplied with the MYTHIC 22 AL. .4 Reagent tray The reagent tray is dedicated to the OnlyOne lysing reagent and cleaning solution bottles. .This module enables to load. Ten racks of five tubes can be loaded.The rack are loaded on the guide rail by a loading screw then displaced by another screw (transfer screw). . GENERAL OVERVIEW 2.REF : M22AL/UM/EN/004 2.4. it is unloaded by the unloading motor. 2.When all the samplings are performed for a rack. The loading can be done continually.4.5 Sampler .The rail which maintains the rack can also rotated for mixing the blood inside the tubes. All Rights Reserved. transfer. MYTHIC 22 AL Copyright© Orphee SA. mix and unload the racks. Page 27/109 . the identification window is displayed.AUTONOMY (run) indicates the number of samples (runs) you can perform (calculated with the smaller quantity of reagents).To change operator during the process. to Page 28/109 Copyright© Orphee SA. 3.To validate or not the modification. . see section 8. .2.After the instrument’s initialization. All Rights Reserved. the last press and enter your password or the identification is not. proceed as described above (section 3.1). and then press on .3. is yours. Place the cursor in the Password window. press return to the main menu.3 o Service people . For the first login. Enter your password for identification.6.1 USER’S IDENTIFICATION 3.1.Biologist Password can be modified in section 3. INSTRUMENT SET UP 3. Either the identification .1. enter your login with the keyboard. MYTHIC 22 AL .To change identification.1 Start Up Machine . .In the window operator’s identification appears.2 In process . MYTHIC 22 AL proposes 3 access levels: o User : No password o Biologist : Password by default 1.7.1. - Enter your identification name with the alphabetic keyboard. INSTRUMENT SET UP REF : M22AL/UM/EN/004 3.1.The window enables to change the language. .3. . the date and the day. Page 29/109 .Press to save. Three pages are required to print all the settings.3 SET UP .REF : M22AL/UM/EN/004 3. . choose the right one in the LANGUAGE combo box. . see section 8. CURRENT SID enables to fix the beginning of the current SID number (which will be used in the AUTO SID number in the work list. INSTRUMENT SET UP 3. print or delete all the settings.To validate or not the modification. All Rights Reserved. see section 5.2) : Biologist reserved for complete settings.PAPER SIZE: Select the paper size per result.1.Press on to have access to the status of the MYTHIC 22 AL. load (RESTORE).The DATE & TIME window enables to modify the time.PRINTER: Select the printer or no printing. .To select the language of the Mythic menu.7.This menu is available for all users. . .Two SID are available. to have access .Different information are displayed: Name of the operator Level of access Name of the cycle in progress Number of racks 3.Press on the date and hour to the system information window. . . MYTHIC 22 AL Copyright© Orphee SA.6.4). START DAY SID enables to select the first SID for each new day. from an USB key. (See section 3.2 SYSTEM STATUS .From the MAIN MENU press on . 4. 3.Please refer below for the description of each key.4.1. US MODE: The Research Use Only message is printed under the printing report. Any modifications may affect the quality of the results.This menu is reserved to biologist (see section 3. percentages are displayed. REPEATABILITY: Enter a number to fix the number of sampling done in the repeatability test in RUN RACK mode (see section 6. .1 Sampler option: RERUN: For each type of blood you can select the conditions: .4. Page 30/109 Copyright© Orphee SA. In the other case.3) . see section 8.1) .4 ADVANCED SET-UP REF : M22AL/UM/EN/004 .OVER PANIC LIMITS: (see section 3. printed and sent. All Rights Reserved.After 3 consecutive flags on the same parameter SAMPLER: The sampler will draw only the blood with a CDB.7.1 Analysis options: .BOLD DISPLAY box: display and print in bold-faced type the different choices in this box.After 3 consecutive clogs on the same parameter .4.1). and mmol. : Gives a choice of three unit systems: Standard. see section 8.6. INSTRUMENT SET UP 3.ON CLOGS: the rerun will be done when one or several parameters are clogged. International System. QC ALARMS: The message “QC failed” appear under the printing report when the QC result is out of tolerance or expired. 3.3.ON FLAGS: (see section 3.6. MYTHIC 22 AL . it is mandatory for the user to enter a ID and/or a PID. We recommend to modify these values only after an Orphee’s training.3) . SAMPLER AUTO STOP: Conditions of sampler stop: . RUO: With tag the PCT and PDW parameters are displayed. the message “QC not done” appear under the printing report when it is not run.1. . ABSOLUTE DIFF: With tag absolute values for subpopulations of leucocytes are displayed.7.To validate or not the modification.To validate or not the modification.OPTIONS box: ALWAYS ID and ALWAYS PID: To run a sample. . 6. see section 8.Press to print the blood type set up.4.4.1 Limits: . .4.1.4.REF : M22AL/UM/EN/004 3.1).This display enables to enter normal and panic limits for every 22 parameters performed by the MYTHIC 22 AL (see section 8).4. parameters: Select the blood type in the combo box then press: panic limits (see section 3. .4.3). To enter a new blood type.4.PRINT allows to print all the blood type set up (about 20 pages are printed) .4. NOTA: No correction factors with type STANDARD. Page 31/109 .2). . INSTRUMENT SET UP 3.Press the standard type. press NOTA: The name of the first STANDARD type cannot be changed. to return to the parameter setting of MYTHIC 22 AL Copyright© Orphee SA. thresholds (see section 3.7.4.4.EXIT to leave the prompt without action. 3. .The limits are those of the type displayed above the table. to adjust the normal and to adjust the parameters to adjust the flags level to adjust the correction factors (see section 3.To validate or not the modification. All Rights Reserved.2 Lab. . (see section 3.4). 0 to 11.1 3. see section 8.0 to 4.64 2.5 to 6.5 to 22.H.8 4.5 0.To validate or not the modification.0 0 to 0.0 to 30.2 4.7.04 to 0.6 to 5. see section 8. INSTRUMENT SET UP REF : M22AL/UM/EN/004 Example of reference values from LABORATOIRE D'HEMATOLOGIE DU C.Press to return to the manufacturer parameter setting.2 1.2 2.Press to check the modification on the scattergram of the last run.To access to modification of the flags threshold press .0 M : 4.0 to 6.8 to 7.3. .1 to 5.0 to 5.0 1. D'ANGERS (FRANCE) First week WBC 103/µL (109/L) Neutrophils (10³/µL) Eosinophils (10³/µL) Basophils (10³/µL) Lymphocytes (10³/µL) Monocytes (10³/µL) RBC 106/µL (1012/L) HGB g/dL HCT % MCV fl MCH pg MCHC g/dL PLT 10³/µL (109/L) 10. MYTHIC 22 AL . .5 0.05 to 0.5 0.2 to 1.85 0 to 0.2 1.5 0 to 0.1.5 M : 40 to 50 F : 37 to 47 82 to 98 > or = 27 32 to 36 150 to 400 3.0 to 18.0 to 13.65 0 to 0. Threshold modifications may affect the quality of the results or the alarm detection area. All Rights Reserved.7.8 to 8.5 F : 12.4 to 3.2 2.2 10.5 to 15.5 0.6.4.8 10 to 16 38 to 44 85 to 96 24 to 34 32 to 36 150 to 400 3 months to 3 years 6.2 to 1.02 to 0. Threshold modifications may affect the quality of the results or the alarm detection area.The threshold display enables to modify the detection thresholds located on the WBC scattergram and RBC.7 0 to 0.5 to 17.05 to 1.0 to 11.0 1.5 0. .5 36 to 44 70 to 86 23 to 31 32 to 36 150 to 400 3 to 6 years 5.1 5. Page 32/109 Copyright© Orphee SA.5 to 8.To validate or not the modification.8 0 to 0.8 to 4.Press to return to the manufacturer’s parameter setting.0 to 10.5 36 to 44 73 to 89 24 to 30 32 to 36 150 to 400 6 to 15 years 5.5 0 to 0.0 0.4 H : 13. .0 1.0 6.5 to 5.2 to 0. .U.5 to 13.1.4 11.5 44 to 58 100 to 120 34 to 38 32 to 36 150 to 400 8 days to 3 months 6.0 to 26.6 0 to 0.5 to 8.0 to 15.0 0 to 0. .0 1. PLT curves (see section 8). .8 4.5 to 13.8 to 5.5 to 8.8 3.0 to 11.5 37 to 45 77 to 91 24 to 30 32 to 36 150 to 400 Adult 4.0 1.5 to 14.8 F : 3.2 0 to 0.3 10.0 0.0 to 8.0 to 10.To accede to modification of the scattergram threshold press . We recommend to modify these values only after an Orphee’s training. We recommend to modify these values only after an Orphee’s training.2 Thresholds: .0 14.0 0. 1.Press to check the modification on the scattergram of the last run. . users can define a correction factor which is multiplied by the calibration factor (see section 3.6. . .The WBC flags appear when the % limits AND # limit are reached. see section 8. Page 33/109 .7) given by a normal calibration (see section 7). MYTHIC 22 AL Copyright© Orphee SA. All Rights Reserved.Press the standard type.In the Alarm menu.7. INSTRUMENT SET UP Threshold modifications may affect the quality of the results or the alarm detection area.4. .3 Flags level: .The RBC and PLT flags appear when the % limit OR # limit are reached . users can modify the sensitivity of the alarms for the different cells: WBC. see section 8.In this menu. . see section 8.1.To validate or not the modification. to return to the parameter setting of 3.Press to return to the manufacturer’s parameter setting.To validate or not the modification.To validate or not the modification.7. PLT and differential (See section 8.4 Correction factors: . 3.5). for each blood type. We recommend to modify these values only after an Orphee’s training.REF : M22AL/UM/EN/004 3.4. RBC. .4.7. .1.6. To select an option on the report.7. press on the corresponding case.3. the user can modify: o Time in minutes to start the automatic shut down. . .4. see section 8. of the of the automatic wake up and its daily time and the day of the week.The entry the biologist password.1 Printer set up: .The entry the date format. use the keyboard.To validate or not the modification. Page 34/109 Copyright© Orphee SA. . . NOTA: The name of the first STANDARD type cannot be changed.Pressure Checking is available for technicians only. All Rights Reserved.To validate or not the modification.2) .To validate or not the modification. . enables to modify enables to select 3.Printer set up menu is intended to present the printing report . .3 Other Setting: . INSTRUMENT SET UP 3.6.7.4. 3. .5 Rename types: REF : M22AL/UM/EN/004 To rename a blood type. o The setting of the automatic cleaning: and its frequency in number of analysis: o The setting . MYTHIC 22 AL .4.In DELAY box. see section 8.1. press then select the box to change and enter the name of the new type with the alphabetic keyboard. see section 8.5. o Time in minutes to raise up the needle.1.To enter a header.Reagent checking enables the reagent control (see section 1.7.1. All Rights Reserved.2. . . .2 Netware Param. MYTHIC 22 AL Copyright© Orphee SA.4. 3. 3.REF : M22AL/UM/EN/004 3.To validate or not the modification.4.To set up the connection between MYTHIC and Host.1 Serial Param.4. .1 Communication: .2.1.Reserved for Field Service Engineer.Reserved for Field Service Engineer. Page 35/109 . INSTRUMENT SET UP 3.Reserved for Field Service Engineer.7. see section 8. . .To validate or not the modification. The modification of any of these factors without running a calibration blood may affect the quality of the result. All Rights Reserved. see section 8.4.A M letter appears on the right of the date of calibration in case of modification in the Calibration Menu.1.1.3 Storage options: MYTHIC 22 AL can save more than the last 1500 patients with results. 3.In this menu. Because the technologies of the USB key are very different some of them may not work. MYTHIC 22 AL . distribution curves in the internal memory and up to a maximum of 60 000 results in a memory stick (USB key) with capacity from 128 Mb to 2 Gb maximum.4. For more information.7.2 Calibration factor: REF : M22AL/UM/EN/004 . Page 36/109 Copyright© Orphee SA.3. . alarms.7. the user can modify the calibration factors without any calibration with calibration blood. .Choose for a FIFO (first in /first out) mode or real time to store the results in the resident memory or in a USB key.To validate or not the modification. INSTRUMENT SET UP 3.. contact your Orphee representative. see section 8. please contact Orphee S.This prompt appears to confirm the version has been successfully loaded. .Place the USB key with the new software in the USB connector at the rear of the MYTHIC 22AL.A. . . All Rights Reserved. If you have any doubt. to load the new software .4.Select the software version to load and press LOAD.4 Version release: Load a new software version only with the agreement of an Orphee’s representative.Press EXIT to exit of the prompt without action.The different prompts hereafter appear to help you during the loading. MYTHIC 22 AL Copyright© Orphee SA. The current software version will be definitively erased and replaced by the new one. . Page 37/109 . .This prompt appears when the release of the software has failed. INSTRUMENT SET UP 3. Be sure to load the new upgrade in the right folder on the USB thumb drive. Press yes only if you are sure you want to load a new version software .Press version.REF : M22AL/UM/EN/004 3. service department or your Orphee’s representative. 4.07 or +/. the total volume could be upper according to the blood remaining outside of the needle). SPECIFICATIONS REF : M22AL/UM/EN/004 4.2% +/. All Rights Reserved.0.0 g/dL HCT < 2% > to 40.0 106/mm3 HGB < 1.2 µl (Nominal volume inside the needle. the results are flagged with a D to indicate that it is necessary to re-dilute and re-run the sample.5% Reportable range: Within the reportable range.5% > to 12. PARAMETERS RANGE 3 3 WBC (10 /mm ) 0 to 100 RBC (106/mm3) 0.(Σx)² N N-1 SD = Page 38/109 Copyright© Orphee SA.0 to 24 HCT (%) 5 to 70 3 3 PLT (10 /mm ) 5 to 2 000 LIMITS (the larger) +/.1 Throughput: ANALYTICAL SPECIFICATIONS Close tube mode: > 40 samples/hour Other vial mode: > 45 samples/hour 18.0.0.0 103/mm3 LYM% < 5% > to 15 % MON% < 10% > to 7 % NEU% < 4% > to 50 % EOS% < 10% > to 5% BAS% < 40% > to 2% RBC < 2% > to 4.3% +/.1 to 8 HGB (g/dL) 1. PARAMETERS REPORTABLE RANGE 3 3 WBC (10 /mm ) 100 to 150 RBC (106/mm3) 8 to 15 HCT (%) 70 to 80 PLT (103/mm3) 2000 to 4 000 Repeatability: Calculated with 20 runs of a fresh whole blood sample performed on a commercial MYTHIC 22 AL. MYTHIC 22 AL .0 % MCV < 1% > to 85 fL RDW < 4% > to 14 PLT < 5% > to 250 103/mm3 PMV < 3% > to 8 fL Calculation method: CV = SD X Σx².5% > to 6.3% +/.2 or +/.3 or +/.4% +/. PARAMETERS CV RANGE WBC < 2. SPECIFICATIONS 4.10 or +/.4 or +/. Sampling Volume: Measurement Principle: WBC/RBC/PLT: Impedancemetry Five part diff: Optical flow cytometry Hemoglobin: Spectrophotometry at 555 nm Hematocrit: Volume integration Linearity: Linearity is measured with linearity sample performed four times for each level. All Rights Reserved.(Low value cycle 3) 100 Accuracy: Results of the correlation done with one commercial instrument (SYSMEX XE 5000® for the MYTHIC 22 AL and HORIBA ABX PENTRA 120® for the MYTHIC 22) and with normal blood samples (without alarm).5 or +/.253 0. SPECIFICATIONS Carry-Over: For each parameter.0 PLT 3000 103/mm3 0.984 0.993 0.991 0.984 0.906 0. Σy R (%) 0. Σx²-(Σx²))(n. MYTHIC 22 vs PENTRA 120 PARAMETERS WBC (103/mm3) LYM (%) MON (%) NEU (%) EOS (%) BAS (%) RBC (106/mm3) HGB (g/dL) HCT (%) MCV (fL) RDW (%) MCH (pg) MCHC (g/dL) PLT (10 /mm ) MPV (fL) 3 3 MYTHIC 22 AL vs SYSMEX XE5000 N 103 97 97 97 97 97 103 103 103 103 103 103 103 103 103 R (%) N 127 113 113 113 113 113 127 127 127 127 127 127 127 127 127 n.187 0.0 HGB 20g/dL 0 < 1. WBC 140 103/mm3 0.950 0.151 0.990 0.(Low value cycle 3) Carry-over = (High value cycle 3) .960 0.896 0.890 0.989 0.997 0. 3 runs are performed from a high concentration sample followed by 3 runs without sample. Σy².2% 0.984 0.935 0.REF : M22AL/UM/EN/004 4.2% 40 or +/.5% 0.940 0.Σxy – Σx.7% MYTHIC 22 AL Copyright© Orphee SA.957 0.963 0.29 < 1.0 High concentration value Measured carry-over (%) Maximum carry-over (%) The percentages of carry-over inter samples is calculated with the following formula: (Low value cycle 1) . Page 39/109 .07 < 1.947 0.993 0.623 0.935 0.746 0.13 < 1.(Σy²)) Mode to mode (closed tube and other vial) acceptable differences: PARAMETERS WBC (103/mm3) RBC (106/mm3) HGB (g/dl) PLT (103/mm3) MEAN DIFFERENCE (whichever is greater) 0.3 or +/.886 Calculation method: r= (n.997 0.988 0.0 RBC 8 106/mm3 0.836 0.954 0.5 or +/. 4” (640*480) Mode landscape Retro-lighted Barcode reader: C39 / Barcode / 2 interleaved 5 > 1500 Files (Demographics.2 PHYSICAL SPECIFICATIONS REF : M22AL/UM/EN/004 General: Ambient temperature: from 18 to 34°C Relative Humidity: 80% maximum at 31°C Storage temperature: -10 to 50°C Altitude up to 3 000 m.) 24V –6. MYTHIC 22 AL .25A DC Weight: Power supply Input: Electrical consumption: During cycle: 60 W (+/-10%) Stand By: 25 W (+/-10%) Maximum: 130 W (+/-10%) Display: TFT Color LCD 8. SPECIFICATIONS 4.) Depth: 430 mm (approx.) Width: 500mm (approx. INSTRUMENT: Dimensions: Height: 410 mm (approx.4.) 25 kg (approx. All Rights Reserved. results and histograms in the internal memory) > 50 000 results in a memory stick (USB key) of 512 Mbit or more (until 8 Gb) QC: 12 levels (200 Files per level) RS 232C Ethernet (TCP/IP) USB Barcode (optional): Memory capacity: Connection: Page 40/109 Copyright© Orphee SA. it should stay at room temperature during 24 hours before being switched on. If the MYTHIC 22 AL has been stored at a temperature lower than 10°C. 0 0.0 4.0 3.1 0.6 0. SPECIFICATIONS * Consumption with one run sample.6 22.9 85.0 0.0 0.0 0.0 0.6 0.8 14.0 0.7 22. POWER SUPPLY BLOCK: Dimensions: Height: 40 mm Width: 70 mm Length: 170 mm Weight: 0.1 0.0 0.0 3.5 0.0 5.8 0.7 14.8 LYSE 1.5 7.8 5.5 CLEANER 0.5 0.0 0.2 13. All Rights Reserved.) Weight: 4.7 47.0 11.4 kg (approx.0 0.) Power supply: Model 120V Model 220-240V 99 to 132Vac 198 to 264Vac 50 to 60 Hz Electrical consumption: 23W (approx.3 1.6 0.0 1.5 0.0 CYCLES Run Sample DIF AL CBC AL DIF Stat CBC Stat Rinse All Back flush Aperture Back flush optics System Init Reagent Prime All Lysis OnlyOne Diluent Cleaner Cleaning Bleach Latex WBC Latex RBC/PLT Adj OPT GCAL Latex OPT Adjust LED Start Up * Shut Down DILUENT 22.REF : M22AL/UM/EN/004 Reagent Consumption (ml): Software Version > V1.0 13.1 3.) Depth: 275 mm (approx.8 37.6 0.4 5.0 0.6 0.4 4.2 0.0 14.0 0.3 0.3 8.) Paper size: A4 Printer: Impact (9 needles) Speed: Up to 300 cps (character per second) MYTHIC 22 AL Copyright© Orphee SA.5 0.7 42.0 12.0 0.2 13.2 0.) Width: 366 mm (approx.4Kg Power supply Input: 90 to 260VAC 1A (rms) for 230VAC – 2A (rms) for 115VAC Power supply output: 24VDC 150W maximum output power PRINTER (LX-300+)(optional): Dimensions: Height: 164 mm (approx.3 1.4 11. Page 41/109 .8 0.6 6.0 1.0 0.2 14.8 1. add one or two run sample DIF consumption if needed. 4. Storage: At room temperature until the expiry date labeled on the bottle. Ingestion: rinse out mouth.3 REAGENTS SPECIFICATIONS All the reagents must be stored at room temperature (18°C to 25°C).9%.1 Diluent ORPHEE code number: HM22-003-10 Opening shelf life: 60 days. First emergency care: Inhalation: Breathe fresh air. Wear a smock. Accidental release and disposal measure : Person related safety precautions: environmental protection: cleaning/collecting: Wear protective equipment. Precautions: Mayn cause skin and eyes irritation.(see section 8) Active components: Others components: Solid content: 0. universal binders. MYTHIC 22 AL . SPECIFICATIONS 4. All Rights Reserved. keep unprotected persons away Do not allow product to reach sewage system or water bodies Absorb with liquid-binding material (sand diatomite. seek for medical advice in case of persisting symptoms Eyes: Abundantly rinse opened eye during 15 minutes. Application: The diluent is used to carry out the necessary dilutions for the measurement performed by the MYTHIC 22 AL. call an emergency center. seek for medical advice in case of persisting symptoms. acid binders. gloves and glasses during manipulation. saw dust) Comply with local and/or federal disposal legislation If any doubt. Description: Clear and odorless aqueous solution. Buffer.3. Skin: not skin irritating. Preservative. Page 42/109 Copyright© Orphee SA. REF : M22AL/UM/EN/004 4. Skin: Abundantly rinse during 15 minutes. and preservatives NOTA: This reagent does not contain any cyanide. until expiry date labeled on the bottle.2 Lytic reagent “OnlyOne” 4. seek for medical advice in case of persisting symptoms Ingestion: give large amount of water. inorganic buffers. (see section 8) Active components: .non toxic Hemoglobin chelate . acid binders. gloves and glasses during manipulation. a non toxic hemoglobin stabilizing chelate. SPECIFICATIONS ORPHEE code number: HM22-002-1 Opening shelf life: 60 days. Page 43/109 . Application: Only One Lytic reagent is used as unique leukocyte and hemoglobin reagent to lyse red blood cells. call an emergency center. universal binders. saw dust) Comply with local and/or federal disposal legislation If any doubt. keep unprotected persons away Do not allow product to reach sewage system or water bodies Absorb with liquid-binding material (sand diatomite. MYTHIC 22 AL Copyright© Orphee SA.3. leukoprotective agents. Wear a smock. enabling cells subpopulations differentiation and counting and quantitatively determining hemoglobin content of blood samples on MYTHIC 22 AL. seek for medical advice in case of persisting symptoms. Storage: Precautions: At room temperature. All Rights Reserved.Leuko-protective agents . neither formaldehyde. seek for medical advice in case of persisting symptoms Eyes: Abundantly rinse opened eye during 15 minutes.REF : M22AL/UM/EN/004 4.alkaline salts and buffering means .Preservatives Description: A clear pale yellow aqueous solution (with slight characteristic smell) composed of alkaline salts. May cause skin and eyes irritation. First emergency care: Inhalation: Breathe fresh air. Accidental release and disposal measure : Person related safety precautions: environmental protection: cleaning/collecting: Wear protective equipment. nor azide.ionic and non-ionic surfactants mix . detergents. keep unprotected persons away Do not allow product to reach sewage system or water bodies Absorb with liquid-binding material (sand diatomite. All Rights Reserved. call an emergency center.3. acid binders. seek for medical advice in case of persisting symptoms Ingestion: give large amount of water.5-10%: Dangerous component with critical values that require monitoring at the workplace (CAS 55-57-6. MYTHIC 22 AL . Enzyme Propylene glycol 2. until expiry date labeled on the bottle.4. Clear aqueous solution. Skin: Abundantly rinse during 15 minutes.3 Cleaning solution REF : M22AL/UM/EN/004 ORPHEE code number: HM22-001-1 Opening shelf life: 60 days. seek for medical advice in case of persisting symptoms. EINECS 200-338-0) OES long term value: 474mg/m3 150ppm total 10mg/m3 particles Violet dye. Components: Description: Storage: Precautions: First emergency care: Inhalation: Breathe fresh air. may cause skin and eyes irritation. universal binders. Wear on a smock. gloves and glasses during manipulation. seek for medical advice in case of persisting symptoms Eyes: Abundantly rinse opened eye during 15 minutes. SPECIFICATIONS 4. saw dust) Comply with local and/or federal disposal legislation If any doubt. Application: The cleaning solution is used to carry out the cleaning of the measurement system and hydraulic circuit (see section 8). Page 44/109 Copyright© Orphee SA. with characteristic smell At room temperature. violet color. Accidental release and disposal measures: Person related safety precautions: Environmental protection: Cleaning/collecting: Wear protective equipment. This is done by the measurement techniques used in the MYTHIC 22AL. RBC. Otherwise. Page 45/109 . in case of myeloma. pregnancy… Platelet aggregation (+) Indication : aggregates may be detected on the Seek for Platelet WBC scattergram with N1 &/or N2 &/or L1 flags aggregates on smear (+): Instrument count is affected by an increase in the result. Plt and Hgb to Warm the specimen up to increase 37°C(99°F) for 30min and Indication: high level of all above mentioned items re-assay immediately after. (?): Instrument count is affected by either an increase or a decrease in the result which is sample dependent. GENERALITIES: Some abnormal samples may give incorrect results by automated cell counting methods. The following table shows examples of specific specimens that could cause errors. N1 &/or N2 &/or L1 &/or on Smear Nucleated RBC Erythroblastosis Indication : NRBC may be detected on the WBC Seek for NRBC on smear. In the case of use of local blood controls or national hematology survey a difference can be observed on the WBC result.4. MYTHIC 22 AL Copyright© Orphee SA.REF : M22AL/UM/EN/004 4.4.2 Interferences Occurrence Possible Indication of Error on MYTHIC 22 AL (+) Parameter Specimen action Cause : high IgM level may lower RBC and increase MCV WBC Cold Agglutinin Indication HL flags (+) Seek for red cell clumping MCV. All Rights Reserved. results may be affected.2. (-): Instrument count is affected by a decrease in the result. Indication : lyse-resistant RBC may be detected on the WBC scattergram with N1 &/or N2 &/or L1 &/or HL flags Cause: In association with various pathologies Cryoglobulins (+) cryoglobulins cause the WBC. 4.4 ANALYTICAL LIMITATIONS 4. See the section 8. leukemia and other proliferative disorders. scattergram with N1 &/or N2 &/or L1 flags Cause: in some rare instance few erythrocytes may Unlysed RBC (+) not be completely lysed. SPECIFICATIONS 4. Each result for a new patient out of lab linearity limits or with an alarm must be checked with a conventional method or checked with blood smear.1 Recommendations MAINTENANCE: Please respect the maintenance procedure and the quality control procedure.2. carcinoma. HCT. scattergram with N1 &/or N2 &/or L1 &/or HL flags WBC scattergram with N1 &/or N2 &/or L1 flags Indication: aggregates may be detected on the Seek for Platelet Cause: These lymphocytes are larger than normal aggregates on smear MON (# & %) Large or atypical lymphocytes (+) lymphocytes and tend to overlap the MON clump on Seek for Erythroblasts on the scattergram smear Indication: reduced LYM/MON gap with LYM band RL flags Cause : These few segmented and granulationsSmall Neutrophils (+) lacking Neutrophils tend to overlap the MON clump on the scattergram Indication: reduced NEU/MON gap with NL flags Cause : Blasts are large and polymorphic immature Lymphoid & myeloid Blasts (+) cells that may overlap all normal cells clumps Indication: reduced/absent LYM/MON even Seek for blasts on smear MON/NEU/LYM gap with overlapping population RL &/or NL &/or HL flags Excessive number of basophils Cause: in case of basophilia the basophils clump may (+) overlap the MON clump on the scattergram Seek for basophils on smear Indication: reduced LYM/MON gap RL &/or HL &/or NL flags Cause: Immature monocytic line cells proliferate in Immature monocytes (+) certain pathologies (multiple myeloma. All Rights Reserved.4. promyelocytes. (?): Instrument count is affected by either an increase or a decrease in the result which is sample dependent. myelocytes. Immature granulocytes (+) blasts or plasma cells are large and polymorphous Seek for immature cells on cells that may overlap NEU clump smear Indication: diffuse spreading out NEU clump NL &/or RL &/or IC &/or L5 flags (+): Instrument count is affected by an increase in the result. MYTHIC 22 AL . Page 46/109 Copyright© Orphee SA. (-): Instrument count is affected by a decrease in the result. monocytic leukemia…) and generate a band at the right of Seek for immature normal MON clump that causes an inaccurate high monocytes on smear level of monocytes. SPECIFICATIONS Parameter LYM (# & %) Specimen Nucleated RBC Erythroblastosis Platelet aggregation (+) (+) REF : M22AL/UM/EN/004 Occurrence Possible Indication of Error on MYTHIC 22 AL action Indication: NRBC may be detected on the WBC Seek for NRBC on smear. Indication: : diffuse MON clump with right-end flame population IC &/or L5 &/or NL flags NEU (# & %) Excessive number of eosinophils Cause: The excessive presence of eosinophils (+) check the eosinophils clump (eosinophilia) may interfere with NEU counting on the scattergram to Indication: EOS clump is overlapping NEU clump NH eliminate eosinophilia flag Cause : metamyelocytes. MCV. HCT Cause: in very rare case of severe microcytosis. MPV. MYTHIC 22 AL Copyright© Orphee SA. Indication: RBC. SPECIFICATIONS Occurrence Possible Indication of Error on MYTHIC 22 AL action Cause: Toxic or abnormal granules. Smear Indication: RBC. NH &/or IC &/or L5 Flags BAS (# & %) Blasts. Plt. Indication : RBC. RBC RBC agglutination (?) Cause: agglutinated RBC may cause a low inaccurate Seek for clumped RBC on Smear Seek for schizocytes on Smear Fragmented RBC (-) Cause: RBC fragments (schizocytes) may agglutinate Cause: high level of WBC may cause an erroneous Leukocytosis (+) Indication: very MCHC high WBC Centrifuge the sample and re-assay the re-diluted RBC (>100. size (-) Seek for red cell clumping on Smear Severe Microcytosis of microcytes may fall under the minimum RBC Seek for microcytes on threshold. Plt R1 &/or P3 flags Macrocytosis (-) Cause : in case of macrocytosis. (-): Instrument count is affected by a decrease in the result. size of macrocytes may overcome the maximum RBC counting zone.000/ L). Indication: abnormal MCH and MCHC values and interfere with RBC counting. part. immature. P2 flag RBC count. as much as EOS (# & %) Granulations modifications (-) degranulated areas may alter optical properties of Seek for Granulations eosinophils and cause an erroneous EOS counting modifications on smear Indication: diffuse downwards spreading EOS clump overlapping NEU clump. All Rights Reserved. R2 flag RBC count.REF : M22AL/UM/EN/004 Parameter Specimen 4. NH Flag Atypical Neutrophils Cause: hyper-segmented or giant Neutrophils may (+) Seek atypical Neutrophils overlap EOS clump on smear Indication: upwards spreading NEU clump overlapping EOS clump. (+): Instrument count is affected by an increase in the result. (?): Instrument count is affected by either an increase or a decrease in the result which is sample dependent. atypical cells Cause: abnormal cells may overlap the basophils (+) clump and interfere with the basophil counting Seek for blasts on smear Indication: absence of LYM/MON(NEU) gap with RL &/or NL &/or HL flags RBC Cold Agglutinin (-) Cause: high IgM level may lower RBC and increase MCV Indication: MCV. Page 47/109 . to determine Hgb Indication: plasma appearance MCHC. (+) Elevation of WBC Seek for red cell clumping on Smear Cause: in case of chemotherapy cytotoxic and (-) immunosuppressive drugs may increase RBC as well as WBC fragility leading to a low HCT Indication: P1 flag Spherocytosis (?) Cause: in case of Spherocytosis. HCT. Or use reference spectrophotometric method hyperlipidemia Cause: in case of high level of lipids in blood will give (+) Use reference manual the plasma a “milky” appearance that causes methods and a plasma blank inaccurate Hgb measurement. Indication: very high WBC (>100. P2 flag (+) Cause: high level of WBC interferes with MCV Use reference manual determination. MCHC the re-diluted RBC part. Abnormal Protein hyperproteinemia. Indication: very high WBC (>100.000/ L) . SPECIFICATIONS REF : M22AL/UM/EN/004 Parameter Specimen Occurrence Possible Indication of Error on MYTHIC 22 AL action Centrifuge the sample HGB Leukocytosis (+) Cause: high level of WBC causes excessive light remove WBC and re-assay scatter that interferes with Hgb measurement. Page 48/109 Copyright© Orphee SA. P2 &/or P3&/or R1 flags Seek for spherocytes on Smear Seek for clumped RBC on Use reference manual methods to determine the accurate MCV value. to determine Hgb Indication: lysed sample appearance MCHC HCT Cold Agglutinin Leukocytosis Abnormal Red Cell Fragility (-) Cause: high IgM level may lower RBC and increase MCV Indication: MCV. Seek for megalocytic platelets on Smear MCV RBC agglutination (?) Cause: agglutinated RBC may cause an inaccurate Smear MCV value. (+): Instrument count is affected by an increase in the result. sphered RBC are smaller than normal RBC leading to a low HCT Indication: MCV.4. hyperbilirubinemia Cause: in case of high level (or abnormal) of (+) proteins in blood will give the lysed sample a Use reference manual “cloudy” appearance that causes inaccurate Hgb methods and a plasma blank measurement. (?): Instrument count is affected by either an increase or a decrease in the result which is sample dependent. Indication: abnormal MCH and MCHC values Megalocytic Platelets Leukocytosis (-) Cause: may cause a low inaccurate MCV value because of an excessive size Indication: Plt MPV . All Rights Reserved. MYTHIC 22 AL . MCHC methods to determine the accurate MCV value.000/ L). (-): Instrument count is affected by a decrease in the result. REF : M22AL/UM/EN/004 Parameter Specimen See Hgb value and RBC count interferences See Hgb and HCT values interferences See RBC count interferences 4. Plt MPV re-assayed Cause: Clumped platelets may cause a decreased PLT Platelet Aggregation (-) Cause: in case of severe microcytosis. Indication: abnormal MCH and MCHC values RBC (+): Instrument count is affected by an increase in the result. (-): Instrument count is affected by a decrease in the result. Seek for Platelet aggregates on Smear platelet count The specimen should be Indication: aggregates may be detected on the recollected in sodium WBC scattergram with N1 &/or N2 &/or L1 &/or HL citrate anticoagulant and flags. (?) MCHC RDW The RDW is determined according to RBC count. microcytes Severe Microcytosis (+) and schizocytes are under the RBC inferior Seek for microcytes on threshold and may be counted with Platelets and Smear cause an erroneously high Plt count Indication: RBC. MYTHIC 22 AL Copyright© Orphee SA. (?): Instrument count is affected by either an increase or a decrease in the result which is sample dependent. All Rights Reserved. The MCMH is determined according to Hgb and HCT values. The limitations listed for Hgb and RBC may cause indirect interferences. The limitations listed for Hgb and HCT may cause indirect interferences. Indication: abnormal MCH and MCHC values Seek for clumped RBC on Smear Hemolysis (+) Cause: hemolysed samples contain RBC stromas that cause a high inaccurate Plt count. Page 49/109 . Plt R1 &/or P3 &/or P2 flags Megalocytic Platelets (-) Cause : may cause a low inaccurate platelet count as these platelets exceed the upper threshold for the Seek for megalocytic platelet parameter and are not counted platelets on Smear Indication : Plt MPV P2 flag RBC agglutination (?) Cause: agglutinated RBC may trap platelets and cause a low inaccurate Plt count. The limitations listed for RBC may cause indirect interferences. SPECIFICATIONS Occurrence Possible Indication of Error on MYTHIC 22 AL action MCH The MCH is determined according to Hgb value and RBC count. . . . 5.3 REAGENT REPLACEMENT The reagents must be stored 24 hours minimum at room temperature before use. Page 50/109 Copyright© Orphee SA. . .Press ON/OFF button on the printer to start. . and the level of the waste container. SAMPLE ANALYSIS 5.If needed switch on the power supply (the power supply can stay on).1.AUTONOMY (run) indicates the number of samples (runs) you can perform in CBC or DIF mode (calculated with the smaller quantity of reagents). All Rights Reserved. SAMPLE ANALYSIS 5.5.1. MYTHIC 22 AL . .Press ON/OFF button on the Mythic. Please also check the paper quantity in the printer.1 VERIFICATIONS BEFORE STARTING REF : M22AL/UM/EN/004 Before starting MYTHIC 22 AL. we recommend to check the reagent levels in each bottle.7. see section 8.The following prompt appears when you switch on the instrument every day. .The initialization menu is displayed and MYTHIC 22 AL performs a home position checking for the three motors of the fluidics and the four motors of the auto loader. If you press YES the work list will be automatically cleared and the AUTOSID will be reset.If one or two racks are always inside the rail.2 SWITCH ON . 5.To validate or not the modification.Enter your login and password as described in section 3. they are transferred to be unloaded. The level should not to exceed the following:  WBC : 0.AUTONOMY (run) indicates the number of samples (runs) you can perform in CBC or DIF mode (calculated with the smaller quantity of reagents).4. press .4 START UP RINSING .2 .5. .REF : M22AL/UM/EN/004 5.To check the level of each reagent. press . . All Rights Reserved. SAMPLE ANALYSIS .An automatic Start Up can be performed at a scheduled time (see section 3. proceed as indicated in section 1.5  RBC : 0. This prompt means This prompt means that the that the temperature temperature setting setting of the of the enclosure enclosure and/or the and/or the reagent reagent is reached is not reached yet MYTHIC 22 AL Copyright© Orphee SA. Page 51/109 .Mythic will perform 1 to 3 blank cycles to check the carry over level.To rinse the system before analysis.8) NOTA The startup can start as soon as the working temperature is reached (about 20 min at 23°C room temperature). MYTHIC 22 AL displays a window “START UP FAILED” press OK and perform a new start up otherwise every result will be printed with “Start Up not done” message.If one reagent or more needs to be replaced.If the level is higher. 5.1  HGB : 0.5  PLT : 10 . 1). 5. The use of another type of sample collection tube may destroy the sampling needle or give false results.2 Blood sample collection tube The following table shows the type of sample collection tubes available with the MYTHIC 22 AL. please contact your Orphee’s representative before using this different type. BD VACUTAINER BD VACUTAINER BD VACUTAINER BD VACUTAINER TERUMO VENOSAFE GBO VACUETTE GBO VACUETTE GBO VACUETTE GBO VACUETTE GBO VACUETTE 368861 368452 367651 367652 VF054SDK 454034 454024 454087 454023 454036 13x75 13x75 13x75 13x75 13x75 13x75 13x75 13x75 13X75 13x75 The SARSTEDT tube request a special optional rack (type 02.6.6. The minimum volume of blood required in the sample tube is 300µl.5 PREPARATIONS BEFORE ANALYSIS 5. The results and/or the number of flags may be affected in case of too much sampling in the same tube.5. the cap which contains the rubber membrane for the piercing module. All Rights Reserved. two or tri potassic) tube in sufficient quantity. around 20 times in function of the type of blood (an aged and/or abnormal blood can be altered before 20 samplings).5.1 Blood collection REF : M22AL/UM/EN/004 The human blood venous sample must be collected in an EDTA K2 or K3 (Ethylene Diamine Tetracetic Acid. The CBC and 5 part diff results are available up to 48 hours after the blood draw and if the sample is stored early at 4 to 8°C (more flags may occur). SAMPLE ANALYSIS 5. Page 52/109 Copyright© Orphee SA. see section 5. A volume of insufficient blood for the quantity of anticoagulant may involve an erroneous result. please contact your tube vendor for more details about EDTA and VACCUM contain. MYTHIC 22 AL . please contact your Orphee’s representative for its supply.5. The close tubes serial numbers below are showed only as examples. The more important close tube characteristics are the length and diameter for the tube holder. It is recommended (or mandatory according to the legislation) to carry out a Quality Control (QC) and possibly a calibration before any analysis (see section 6 & 7). 4. is automatically generated. before beginning the series. NOTA: The MYTHIC 22 AL is delivered with a standard parameter setting described in section 3. it is duplicated in the work list. .SID is unique for a patient in a work list. 6. 2.In case of manual match performed by the operator. 2. the sample is run and its result is identified by the RAC/POS.6.The results are never matched with in progress (P) or unmatched (U) order. 7. the letter M will appear on the printout.When a rack is finished. it is recommended to perform two analyses on a normal sample the day before to check the results are closed to results obtained the day before.If an order is rerun.2 Working rules General rules: The analysis of a sample (in RUN RACK or RUN NEEDLE mode) can be run after all fluidics cycles except the SHUT DOWN after which a START UP is mandatory and DRAIN ALL after which a RINSE ALL is mandatory. SAMPLE ANALYSIS All the maintenance (see section 9. the orders corresponding become Unmatched (U in the column Status). Read the analytical limitations (see section 4. Sampler: The setting rules of working of the rack system are defined in section 3. and in case of sample tubes missing in the rack.6 ANALYSIS 5.Once a sample is analyzed the result is associated with its order.4. The samples can be run in two sampling modes: . see section 3.Nothing can be changed when the run is in Progress (P in the column Status). The working temperature of the fluidic part must be reached before starting the analysis.3 to set up the number.7). an order with AUTOSID with an incremental number initialized at each beginning of day.SID is mandatory.6.REF : M22AL/UM/EN/004 5.1 Introduction 5.4) before running the sample.Barcode exclusive: this mode allows the maximum security because only the tubes with a barcode label and read by the MYTHIC 22AL are run.When an Order is Done (D in the column Status) only the test and the RACPOS can be changed (for the rerun in rack or needle mode).RACPOS is always unique for the order To do (T in the column Status).4 (Sampler Options).8).6.Closed tube with the use of the racks (see section 5. All Rights Reserved. Security rules: 1. The quality of the results cannot be insured if the maintenance is not done. Association rules: 1. if the result cannot be associated. Two modes are possible: 1. 2. The average time to reach it is around 20 min at a room temperature > 23 °C.STAT with open tube or other vial only (see section 5. 5. 5. 3. 3. If the quality control is not carried out. Page 53/109 .1) must be done before running any samples or controls.6.Barcode and RAC/POS: If the barcode label is not present or in case of non reading. MYTHIC 22 AL Copyright© Orphee SA. no error is possible. 2) or manually.To modify an existing demographic data. .The work list allows to follow the demographic data of each sample to be run. SAMPLE ANALYSIS 5. press (see section 5.The list can be filled out directly from the LIS (see section 3. .7) is the Position of the tube inside the rack (see section 5.7) is the Status of the samples: To do (T).6.6.4.Press on to delete all.6. press (see section 5.6. Done (D). MYTHIC 22 AL .To display the full result in progress.7) is the number of the Rack (see section 5.Meaning of the columns : is the Type of rack (see section 5. press section 5. press see section 5.5.3 Work list REF : M22AL/UM/EN/004 .6. All Rights Reserved.6.Other columns (modifiable in the following sections): : Sample Identification : Patient Identification : Identification : Type of test requested (CBC or DIF) : Male or Female or Unknow : Date of the blood drawing : Time of the blood drawing : Prescriptor : Origin of the sample : Comments . . print or save in internal memory the complete worklist.To enter the demographic data of a new sample. .To run an emergency sample (STAT). delete the selected order.6) . done but Unmatched (U).8).5) .Press to access to the work list .RESTORE allows to load a worklist from an USB key and BACKUP allows to save the worklist into an USB key (see Page 54/109 Copyright© Orphee SA. In Progress (P).6. .6.4 . Select the box and enter the modification with the keyboard.8).6.1. . . press or is only available when the sample become Done (D).To validate or not the modification. press the last sample. press (see section 5.To come back to the work list.5 New Order . the screen is updated with the last result. .6.At each analysis.6. press . Page 55/109 . see section 8. . .To stop the racks in progress to run a emergency sample or for any other reason. 5.This screen allows displaying the last result in progress and its demographic data.To run this patient in STAT mode or open vial mode press (see section 5.Enter the demographic data of the new patient with the keyboard.6.1. . The movement of the rack stops.8). . The analyze re-start at MYTHIC 22 AL Copyright© Orphee SA.6.REF : M22AL/UM/EN/004 5.To run this patient in STAT mode or open vial mode press (see section 5. SAMPLE ANALYSIS 5. . press or . then .To run this patient in STAT mode or open vial mode. then the fluidics stops. To re-launch the rack. . 5.7.7.4 Modify an order NOTA: A patient order can be modified until the blood is drawn.8).To come back to the work list.To come back to the work list press or is only available when the sample become Done (D). All Rights Reserved.To validate or not the modification. see section 8.6 Display run . . .6. 2) and the number of the rack 05.The barcode labels at the bottom of the rack are used to know if a sample tube is present. . . Never use a rack with a non dedicated sample tube. unknown code…) only the rack position (RAC/POS) will appear with the result (see section 5. . please refer to the section 5. All Rights Reserved.2). . .5.7).Good position of the label. .5. If no rack exists for a special vial.7 Run Rack REF : M22AL/UM/EN/004 5. altered. the type is tube) and the rack number 02 (dedicated only for the SARSTEDT 02 Before loading the sample tubes in the rack.6.5. the type is 01 (dedicated for the type of tubes listed in section 5. the needle may be destroyed and the results may be erroneous (See the authorized tubes in section 5.6.Bad position of the label. NOTA If the barcode of the sample cannot be read (bad position.In this example.6.7.The label situated at the top of the rack allows identifying the type and the number of the rack.The arrow helps the user to introduce the rack in the good position inside the loader. Before load the rack with the sample tube. . .1 Preparation before loading Wear rubber gloves and wash hands with a disinfectant after completion of work. MYTHIC 22 AL . check if all the caps are perfectly closed.The barcode label of the sample must be placed in front of the rack.8 to run it. SAMPLE ANALYSIS 5. If the barcode of the rack is missing or altered. check if all the barcode labels are not altered. the rack will be ejected automatically.In this example. .The barcode label of the sample must be placed in front of the rack. Page 56/109 Copyright© Orphee SA. .The barcode label situated between the first two positions is dedicated to identify the type and the number of the rack. Run a STARTUP (see section 5.5. If the racks are in bad position or not present the auto loader does not start or stop and a prompt NOTA appears on the screen to inform the user that no rack is present.When everything is ready press NOTA on the following page). . .4).6. the which cycle is in progress and wait for the green light other racks may be added at any time on the first one.4. All Rights Reserved. press between the screen and the front door located at the top of all screens to see .2 and followings). . .6 .The round white label must be placed on the left of the instrument.6.This prompt appears if the STARTUP has not been done . .7.REF : M22AL/UM/EN/004 5.The run of the rack can be launched after having done the demographic entries (see section 5.Introduce a rack or place it in the good position.Place the rack in the right position as shown on the picture.4) otherwise a message “Startup not done” will be printed on all results printings.2. (read the . SAMPLE ANALYSIS To perform an emergency stop in case of any problem push shortly on the on/off button section 9. MYTHIC 22 AL Copyright© Orphee SA.The sampler will work as defined by the user in the Set up (Sampler Options section 3. Before launching the sampler you must read all the section 5. and see Before loading the FIRST rack when the MYTHIC 22AL is operating (the light is red).2 Loading and analysis NOTA 5. Page 57/109 . Page 58/109 Copyright© Orphee SA.2 to restart the sampler. . All Rights Reserved.5. and see section NOTA The analysis can start as soon as the working temperature is reached (about 20 min at 23°C room temperature). MYTHIC 22 AL .The rack can be re-used to load new samples.2.5. See section 9. NOTA Never breach the exit of a rack. This prompt means This prompt means that that the temperature the temperature setting setting of the of the enclosure and/or enclosure and/or the the reagent is reached reagent is not reached yet 5. To remove each sample.6. then take it by the cap. put the rack on the table and push on the bottom of the tube. push briefly on the on/off button 9. SAMPLE ANALYSIS NOTA REF : M22AL/UM/EN/004 To perform an emergency stop in case of any problem.5.The racks are unloaded from the sampler automatically. otherwise the sampler will stop in emergency.3 Unloading .7. REF : M22AL/UM/EN/004 5. All Rights Reserved.From the work list.8 STAT or other vial Sample Identification . SAMPLE ANALYSIS 5.To validate the modification or not.7.To come back to the work list.To run the sample in STAT mode or Open vial read hereafter. .4. select the line then press . press table. MYTHIC 22 AL Copyright© Orphee SA. .From the main menu. Page 59/109 .5 Work list Options).6. .To run this patient in STAT mode or open vial mode. press . to reach the work list . select the demographic data of the sample to be run (the line becomes orange) or: To enter the demographic data of a new sample press To modify an existing demographic data. see section 8.The setting of the work list can be modified in the Set up (see section 3. press . .Select the box and enter the modification with the help of the keyboard.1. press or is only available when the sample become Done (D). Page 60/109 Copyright© Orphee SA. wait for the complete stop. The barcode reader is a laser CLASS II.Before launching the run.8) .2 . beware to stay away from these parts if they move when the front door is open and the machine switched on. MYTHIC 22 AL .5. SAMPLE ANALYSIS 5.5. This prompt means that This prompt means that the temperature setting the temperature setting of the enclosure and/or of the enclosure and/or the reagent is not the reagent is reached reached yet .Press on the display of the WORKLIST screen. otherwise see section 9. close it. NOTA The analysis can start as soon as the working temperature is reached (about 20 min at 23°C room temperature). never dismantles the cover. enter the identification of the sample (see section 5.If the sampler is running. this prompt appears: . switch off the AL and call Orphee representative. in case of problem call Orphee’s representative. Behind the front door you will find hazardous moving parts.6.9 STAT or other vial sample run REF : M22AL/UM/EN/004 Wear rubber gloves and wash hands with a disinfectant after completion of work. if the red light is present during the opening of the door. All Rights Reserved. Be careful with laser light of the barcode reader.The door goes down slowly.Open the front door by pushing on the mark . the red light door becomes green and a prompt appears on the located between the screen and the front screen: Never open the door before the complete stop of the sampler.6. close the door by pushing the top of the door.9).At the bottom of the screen.Introduce the tube of the blood sample without cap under the needle. allows MYTHIC 22 AL Copyright© Orphee SA. Press in this zone to have a clear explanation of the flags. 5. .7 DISPLAY RUNS .7).6.6. All Rights Reserved. the MYTHIC 22 AL is available for the identification of the following sample (See section 5. . the SID is automatically incremented and. .The results are sent to the selected unit (See section 3). .The green LED becomes red the tube can be removed only when the needle is up.5). ). .A new cycle can be started again when it becomes again green (return to section 5. allows coming back to the Work list screen and launching a run in Open Vial mode (See section 5.Open the door if this prompt appears. Page 61/109 . starts.Press YES in the new prompt to launch the analysis cycle.7 to identity the sample).4) otherwise a message “Startup not done” will be printed on all results print.As soon as the cycle is launched. . . .Run a STARTUP (see section 5.Under the results. a zone (FLAGS) is reserved for analytical alarms (see section 8.This prompt appear if the STARTUP has not been done . .REF : M22AL/UM/EN/004 5. . . .The scattergram and curves of distribution of each cellular population are located on the right screen.The results of the analysis are sent before the cycle is finished (to be checked) at the same time as the printer NOTA: It is not necessary to wait for the end of the result printout to launch a new analysis.Press YES in the prompt to allow the needle go down. SAMPLE ANALYSIS .The information located on the right of each parameter corresponds to the indicators for out of range limits and for the rejections (see section 3).6. thanks to its data processing multitasks.After running the samples. . . .5. this proposal is a commitment.5 to understand the flags’ meaning. . It is mandatory to read the section 8. press .With regards to the different flags found by the MYTHIC 22 AL the upper part proposes a list of the cells to be checked on the smear.To send the result.Press on the flags’ zone to open the flags’ window.2). SAMPLE ANALYSIS REF : M22AL/UM/EN/004 . .To close the window.5 to understand the flags’ meaning.To print the result press . .5. MYTHIC 22 AL .The lower part describes the machine trouble (see section 8. Page 62/109 Copyright© Orphee SA. . All Rights Reserved. press . .Press to reprint or to resend the result. it is mandatory to read the section 8.Example of an abnormal result analysis in DIF mode with flags located at the right of the results and in the flag box under the result. In no case. 3. the MYTHIC 22 AL prints a result report.1. 5. Page 63/109 . All Rights Reserved. see section 3.1 PCL3/LX 300 (USB) model report One result per page DIF mode CBC mode MYTHIC 22 AL Copyright© Orphee SA. To load a new printer driver.8 PRINTING Once the analysis is finished. see section 3. SAMPLE ANALYSIS 5. To modify the printing presentation or to disconnect the printers.4.8.REF : M22AL/UM/EN/004 5. 8. All Rights Reserved.5.1 PCL6 model report Page 64/109 Copyright© Orphee SA. SAMPLE ANALYSIS Two results per page DIF mode REF : M22AL/UM/EN/004 CBC mode 5. MYTHIC 22 AL . . TECHNICIAN: Login with the service Technician password.Select to print or save the logs of the number of pages indicated on the screen. BLEACH: Bleach cycle. SUPERTEC: Login with the “Super” service Technician password.MYTHIC 22 AL manages a simplified log allowing to save and display all the events performed each day for the following actions: BIOLOGIST: Login with the Biologist password. . select enter the starting day and ending day.REF : M22AL/UM/EN/004 5. START UP FAIL: Start Up cycle has failed. CLEANER CHANGE: Cleaner replacement. press .9 LOGS INTERVENTIONS From the main menu. LYSIS CHANGE: Lysis replacement. START UP: Start Up cycle has been performed. then MYTHIC 22 AL Copyright© Orphee SA. All Rights Reserved. INTERVENTION: An intervention or maintenance has been performed. Page 65/109 . DILUENT CHANGE: Diluent replacement. Each column is identified by its date. AUTOCLEANING: Auto cleaning cycle. press to reach the logs’ display . CALIBRATION: Calibration. SHUT DOWN: Shut down cycle has been performed. SAMPLE ANALYSIS 5. QUALITY CONTROL: Quality control DELETE RESULTS: Results deleted in Archive.To print or save the log report.To print or save the logs of one or more days. Press to enter the archive display. are the demographic data of the selected result.2 allows an access to the results date list.The column RES indicates the number of results in memory.7). select the required SEQ number.10. distribution curves in the internal memory and up to a maximum of 60 000 results in a memory stick (USB key) of 512 Mbit or more (see section 3. .To view an entire result. (see section 5. MYTHIC 22 AL . month and day to display the results.Each result is saved in a work list of the day. under the table.The Archive display allows viewing the results of the analysis. .The buttons .At the bottom of the display.10.Press to see the table of results.The results of the patients are given in column. .The first column gives the name of the different parameters. . select the required result (identified in blue). the first line the result number. press on the column of the result. alarms. .5. . located under the table. .A value in bold means out of the normal limit and a value in white on black mean rejection. .1 Results . 5. allow changing pages. Page 66/109 Copyright© Orphee SA.10 ARCHIVE REF : M22AL/UM/EN/004 MYTHIC 22 AL can save more than the last 1500 patients with results. . All Rights Reserved. . .4.To find a result in the list. then press hereafter). .Select the right year. SAMPLE ANALYSIS 5. allow displaying each .Keys and result and its identification. Page 67/109 .To send. . the selected results will be deleted from the internal memory and stored in the USB key.Then press on SEND. If you press YES. . NOTA: the printed report is a list of all selected patients. SAMPLE ANALYSIS . archive main page. for printing.2 View .10. Selected results: Select the first and the last results: with the numeric keyboard. send. send. .REF : M22AL/UM/EN/004 5.This prompt informs that the storage has been unsuccessful. 5.This prompt allows follow-up the storage. press MYTHIC 22 AL Copyright© Orphee SA. delete or save (in a USB key) : . try another USB key.To come back to the Main Menu. press .The printed report covers one full page with one or two results per page. . All Rights Reserved. All results: Press . delete or save (in an USB key) results. SAVE and DELETE (the selected result) or DELETE ALL. print.It is possible to print. delete or save results press . To come back to the . PRINT. press . . .To exit the prompt without action.To print. . press EXIT. MYTHIC 22 AL automatically stops. Selected results: select the first and the last results: with numeric keyboard.It is possible to send.1. it is impossible to perform an analytical cycle without launching a start up cycle. and DELETE or SAVE. .At the end of the cycle. All Rights Reserved.Shut Down can be automatically performed after a setting time (see section 3. All results: Press . . .2) MYTHIC 22 AL must stay at rest with cleaning solution during three hours every 24 hours or replaced by a bleach cleaning done each day instead of each week (see section 9. print.6) NOTA: After a shut down.4. delete or save: . press EXIT. SAMPLE ANALYSIS REF : M22AL/UM/EN/004 . MYTHIC 22 AL . . delete or save results. for printing. Page 68/109 Copyright© Orphee SA. print.All the hydraulic circuits are rinsed.To exit the prompt without action. MYTHIC 22 AL automatically performs a shut down cycle. . (see section 5. the 5.Then press on SEND. press .5. and then cleaned with the cleaning solution.From the main menu. PRINT.To send.2).11 STAND BY AND SHUT DOWN . press . . . . QUALITY CONTROL 6.To choose another lot. In the case of use of local blood controls or national hematology survey a difference can be observed on the WBC result. allows restoring the data from an USB .REF : M22AL/UM/EN/004 6. it is recommended to run a control blood at the beginning of each working day before running sample. press on the required lot. . To view the result table.1 INTRODUCTION Quality control allows checking the stability of the MYTHIC 22 AL analytical performances when operating.The key allows the modification of the identification and the target values. Results of each lot can be viewed in tables and Levey-Jennings graph. 6. to have access to the quality control .Myt-5D Normal level code number MYT506 The control blood must be used before its expiry date and stored according to the manufacturer’s instructions for use. See the section 8. In case of exceeding the tolerances indicated on the blood control result sheet. .2 QUALITY CONTROL MYTHIC 22 AL stores in memory up to 100 results per lot for 12 different lots. MYTHIC 22 AL Copyright© Orphee SA.2. All Rights Reserved.The last active lot is labeled with a dark dot on the left lot. .The key allows: . This is done by the measurement techniques used in the MYTHIC 22AL.Press menu. . To perform quality control analysis.2. QUALITY CONTROL 6. In case of no specific local regulations. Orphee recommends using the following controls: . It must be well-mixed before use according to the instructions for use. Page 69/109 . .The key key.Quality control display presents the identification of the lots.Myt-5D tri level code number MYT502 . it is recommended to perform a calibration (see section 7). 6. o SEND: to send targets.7. o PRINT RESULTS: print the results. see section 8.2.To load target values and limits press LOAD. press . then press the appropriate button.To print or send the targets. . QUALITY CONTROL REF : M22AL/UM/EN/004 . MYTHIC 22 AL .1 Change .In this display. o PRINT TARGETS: print the targets. Page 70/109 Copyright© Orphee SA. o EXIT: to leave the tool without action. . All Rights Reserved. the user can enter the: o Lot number o Expiry date o Target values and tolerances o Level o Select DIF or CBC mode. . results and graphics to a host.The prompt display the lots available in the USB key. o SAVE: to save targets. o PRINT GRAPHICS: print the LJ graphics. 6.Select the good lot and press LOAD. results and graphics in the USB key.To validate or not the modification.1 .Tag the lot number to select. results and graphics. MYTHIC 22 AL Copyright© Orphee SA. .To run a control blood analysis in open tube mode.To print. QUALITY CONTROL 6. run after run. press .The results are displayed in line.REF : M22AL/UM/EN/004 6. . . . Page 71/109 . send or delete a result selected. .Press LJ to open the Levey-Jennings graph screen.The column SEL allows selecting or unselecting a result (the statistics are done with the selected results only). o Press and repeat this operation as long as needed (maximum 20 runs). . All Rights Reserved.The statistics calculations are shown at the bottom of the display and are automatically done after each run.2 Run control blood This screen allows running a control blood to check the precision of the MYTHIC 22 AL.2. o SEND: Send the results.To run repeatability.The column SEL allows selecting or unselecting a result (the statistics are done only with the selected results). see section 3. . . All Rights Reserved. . Page 72/109 Copyright© Orphee SA. run after run. QUALITY CONTROL 6.4. .6.The results are displayed in line. MYTHIC 22 AL .4) o Enter the RAC/POS of the sample to analyze o Press It is mandatory to change for a new cap after a maximum of 20 piercings.The statistics calculations are shown at the bottom of the display and are automatically done after each run. .To run repeatability in open tube mode: o Press and repeat this operation as long as needed (maximum 20 runs).To run repeatability analysis in Rack mode: o Check the number of sampling (to change.Press EXIT to exit the prompt without action.The key allows doing the following actions: o PRINT: Print the table.3 REPEATABILITY REF : M22AL/UM/EN/004 . o SAVE: Save the results in USB key. first press This screen allows carrying out a test of repeatability on all the parameters measured by the MYTHIC 22 AL. . . o DELETE ALL: Delete all the results. o EXIT: to leave the TOOLS without modification. o The target values. press .5) MYTHIC 22 AL Copyright© Orphee SA. o SAVE: to store these information in the USB key. that means that the last calibration was done by manual modification of the calibration factor (see section 3. press . then o PRINT: to print these information (see the print out report above). press the key from the main menu.REF : M22AL/UM/EN/004 7. . It should be mixed and stored in accordance with the instructions of use recommended by the manufacturer. . NOTA: If the M letter appears on the right of the date of calibration. o The last date of calibration. All Rights Reserved. o The operator’s name. CALIBRATION The calibration of the MYTHIC 22 AL should be carried out only if the QC carried out on a blood control used according to the recommended conditions is significantly out of the limits (see section 6). .Myt-Cal code number MYTCAL2 The calibration blood must be used before its expiry date.Press .This menu sends the following information: o Lot number of the last used calibrator.4. CALIBRATION 7. o The current coefficients of calibration. o SEND: to send these information. Page 73/109 .To enter new values or to modify the values.To calibrate. . .To reach the screen Calibration. Orphee recommends using the following calibrator: . o The expiry date of the current lot. 2 Calibration Before starting the calibration.1. see the following section hereafter. NOTA: The results of the analyses performed on one calibrator during the same day remain in the memory and are used for calculations if they are selected.1).The results are displayed in line run after run. .To calibrate one or more parameters: Select the parameter Press the key To exit without action.1. This screen allows carrying out the calibration on the parameters measured by the MYTHIC 22 AL.1. To delete the results.1 RUN CALIBRATOR 7. All Rights Reserved. .To run calibration in open or other vial tube mode: o Press and repeat this operation as long as needed (maximum 10 runs). Press or (see below the print report) .1 Calibration blood analysis REF : M22AL/UM/EN/004 This screen allows running analysis on calibration blood to perform the MYTHIC 22 AL calibration. press Page 74/109 Copyright© Orphee SA. 7.The statistics calculations are shown at the bottom of the display and are automatically done after each run. . . .The column SEL allows to validate or to unselect a result.To calibrate. unselect the results you do not wish to use for the calculation of the calibration (See below section 7.7. Press To print the results. MYTHIC 22 AL . . CALIBRATION 7.From the previous menu the key allows: To calibrate with the selected results. Select the lot number Select the field to be modified. Enter your new value with the numerical keyboard or with the alphabetical keyboard.The prompt display the lots available in the USB key.1. Press to load the target and tolerances values and expiry date and lot number from an USB key. Any modification (lot number. CALIBRATION Model of print out calibration report: 7. All Rights Reserved.To modify information relative to a batch or to create a new batch. MYTHIC 22 AL Copyright© Orphee SA. . To validate or not the modification. press .7. date or target values) involves the deletion of all the associated results still in memory. please follow the following steps: From Calibration Menu.REF : M22AL/UM/EN/004 7. Page 75/109 .Select the good lot and press LOAD.2 TARGET VALUES MODIFICATIONS . . see section 8. TECHNOLOGY REF : M22AL/UM/EN/004 8. 8. VACUUM Aperture Electrode Detection area VOLT Proportional height to the cell volume Voltage impulse et the electrode terminal TIME Counting Impulse Page 76/109 Copyright© Orphee SA. RBC. A voltage impulse is registered at the electrodes terminal. PLT Counting The counting of the cellular elements in a blood sample is done with the impedancemetry technique. The height of this impulse is proportional to the cell volume. MYTHIC 22 AL . TECHNOLOGY The innovative technology of the MYTHIC 22 AL is covered by six filed or pending patents. They oppose their physical volume to the course passage. A new innovative concept of optical measurement system and a unique lysing reagent were developed to obtain a so small and powerful analyzer. All Rights Reserved. A vacuum applied on a side of the aperture allows the cells passage.1.1 DETECTION PRINCIPLE 8. This technique is based on the modification of the impedance of a calibrated aperture soaking in an electrolyte and going through a constant course delivered by two electrodes located on both sides of the aperture.1 WBC.8. . Page 77/109 .High resolution matrix.Sample LIGHT INTENSITY WBC CELL OPTICAL DETECTION AREA SAMPLE FLOW TIME ALL For each cell throwing the optical detection area. The sample flow is introduced in the flow cell under pressure and the sheath is only dedicated to maintain it.2 Five part diff measurement The innovative optical detection system is covered by two pending patents.Injector . This principle enables to introduce a large quantity of samples and to use a great dilution rate (which allows doing the Hemoglobin measurement with the same dilution). one for the Axis Loss Light (ALL) measurement and one for the Forward Side SCatter (FSC) measurement.Optical window .High level of reliability of the optical adjustment. two pulses are generated. . All Rights Reserved. .Light beam (455 nm wavelength) . . FSC MYTHIC 22 AL Copyright© Orphee SA.No hydro focusing system.1. . The result of those two axes of measurement is the high definition matrix that enables to identify five WBC populations.REF : M22AL/UM/EN/004 8.Low level of contamination between two measurements.Passive sheath . .Only one passive sheath with low reagent consumption.Only two measurement axes for five parameters. TECHNOLOGY 8.Sample flow . The main advantages are: .Very low cost flow cell (injected plastic). . This technology (called OCHF for Optical Cytometer Hydrofocus Free) is based on an unique and innovative concept of an active sample flow and a passive sheath. the other ten parameters are obtained by flow cytometry measurement (see section 8. This reagent destroys the RBC and their stromas.2) Parameters White Blood Cells Lymphocytes in percentage Lymphocytes in value Monocytes in percentage Monocytes in value Neutrophils in percentage Neutrophils in value Eosinophils in percentage Eosinophils in value Basophils in percentage Basophils in value Pathologies (adjustment section 3. EOSINOPHILS ALL NEUTROPHILS BASOPHILS MONOCYTES FSC LYMPHOCYTES 8.2.1.1) Leukocytosis : WBC>WBC h Leucopenia : WBC<WBC b Lymphocytosis : LYM>LYM h (% &/or #) Lymphopenia : LYM<LYM b (%&/or #) Monocytosis : MON>MON h (%&/or #) Neutrophilis : NEU > NEU h (%&/or #) Neutropenia : NEU < NEU b (%&/or #) Eosinophilis : EOS > EOS h (%&/or #) Basophilis : BAS > BAS h (%&/or #) WBC LYM% LYM# MON% MON# NEU% NEU# EOS% EOS# BAS% BAS# Page 78/109 Copyright© Orphee SA.2 LEUKOCYTE ANALYSIS 8. An automatic offset circuit for the LED 555 nm allows maintaining the blank level at the same range. by spectrophotometry at 555 nm. It is not necessary to adjust this range with a potentiometer.1 Measurement The leukocyte number analysis is done by impedancemetry in the WBC counting chamber.2): All the thresholds of the differential are adjustable in the 20 blood types (see section 3. composes the oxy hemoglobin chromogen and protects the white blood cell membrane to keep it in closed native state.8. A measurement of the blank of hemoglobin is done for each analytic cycle and during the start up rinsing step.4. All Rights Reserved. 8. TECHNOLOGY REF : M22AL/UM/EN/004 The five part diff is obtained by the optical matrix analysis after action of the lytic reagent (pending patent).3 Hemoglobin measurement The hemoglobin measurement is directly done in the WBC chamber.1.4. Hemoglobin is detected by formation of a chromogen oxy hemoglobin type (cyanide free technique). MYTHIC 22 AL .4.4. The WBC can be lower than the expected results. The local blood controls manufacturers or national hematology survey providers must be informed of this limitation. It is well-known in cytometry than the use of fixed cells increase the FSC signal. All Rights Reserved. regarding a control blood. for the lymphocytes. Result obtained on a CONTROL blood: ALL Others cells Lymphocytes Electrical threshold FSC For a control blood. the manufacturer of the control bloods must use smaller fixed cells which appears.2 Local blood control limitations In the case of use of local blood controls or national hematology survey a difference can be observed on the WBC results. are not considered. The left peak is the lymphocytes and the right peak all the others WBC cells.REF : M22AL/UM/EN/004 8. under the electrical threshold on the WBC curve and therefore. the resistive WBC counting is lower than the real number of cells inside the control blood. The fixed membranes of the cells give a more important deviation of the light beam compare to the same membranes without fixation. It appears therefore evident that. The use of smaller cells is necessary because the fixation of the membrane increase the measurement of the FSC signal. TECHNOLOGY 8. This is done by the measurement techniques used in the MYTHIC 22AL. in order to allow to have the lymphocytes in the lymphocyte area in the scattergram.2. Page 79/109 . Result obtained on a normal FRESH blood: ALL Others cells Lymphocytes Electrical threshold FSC The number of WBC is done by counting all the cells in the curve between the electrical threshold to the end of the curve. MYTHIC 22 AL Copyright© Orphee SA. This parameter evaluates the RBC anisocytosis. RDW = k ● SD MCV Wintrobe constant calculation: The Mean Corpuscular Hemoglobin (MCH) calculation is made from HGB and RBC by the formula below: MCH = HGB ● 10 RBC The Mean Corpuscular Hemoglobin Concentration (MCHC) is made from HGB and HCT by the formula below: MCHC = HGB ● 100 HCT Page 80/109 Copyright© Orphee SA. Seven parameters are obtained: Parameters Red Blood Cells Hemoglobin Hematocrit Mean Corpuscular Volume Mean Corpuscular Hemoglobin Mean Corpuscular Hemoglobin Concentration Red blood cells Distribution Width Pathologies (adjustment section 3.4. RDW is an expression of the standard deviation divided by MCV.1) Erythrocytosis : RBC>RBC h Anemia : HGB < HGB b Microcytosis : VMC<VMC b Macrocytosis : VMC>VMC h Hypochromia : MCHC<MCHC b Cold Agglutinin : MCHC>MCHC h Anisocytosis 1 : RDW>RDW h1 RBC HGB HCT MCV MCH MCHC RDW Hematocrit (HCT) is measured by integration volume of all of the red blood cells which flow in the RBC counting chamber aperture.4.3 ERYTHROCYTE ANALYSIS REF : M22AL/UM/EN/004 The erythrocyte analysis is done by impedancemetry in the RBC counting chamber and by analysis of the hemoglobin inside WBC chamber as previously described. MCV is obtained by calculation. All Rights Reserved. TECHNOLOGY 8.8. following the formula: MCV = HCT ● 10 RBC The RBC distribution curve analysis allows the measurement of RDW. MYTHIC 22 AL . HGB. PLT. XXXD: Higher than linearity limits but lower than the reportable limits.5.4. These flags allow the user to be warned if there is a problem which may affect the quality of the results.2 for DIF parameters). PLT and HGB (see section 8. WBC. ----: Rejected value. RBC. 8. All of these flags appear on the right of the result. In presence of one or more flags. HGB. h: results higher than normal value. PLT. +++D: Higher than the reportable limits.4. B: results lower than panic value. WBC. RBC.5. Page 81/109 . XXX *: Counting or measure rejection.5 FLAGS MYTHIC 22 AL manages 25 different flags.1 General Flags The following alarms are common for all parameters.5. can appear with WBC. HCT. Thrombocrit (PCT) is made from PLT and MPV by formula below: PCT = PLT ● MPV 10000 8. MYTHIC 22 AL Copyright© Orphee SA. b: results lower than normal value. NOTA: Most of these flags can be modified by the user (see section 3).3 for HGB and section 8. Four parameters are obtained: Parameters PLT MPV PDW PCT Platelets Mean Platelet Volume Platelet Distribution Width Thrombocrit Pathologies (adjustment section 3.4 ANALYSIS OF PLATELETS Platelet analysis is made by impedancemetry in the RBC counting chamber at the same time with red blood cells. HCT. H: results higher than panic value. it is recommended to check the result by a conventional measure or on blood smear.1) Thrombopenia : PLT<PLT b Thrombocytosis : PLT>PLT h Giant platelets : MPV> MPV h The analysis of the platelet distribution curve allows measuring the Mean Platelet Volume (MPV) and the Platelet Distribution Width (PDW). All Rights Reserved.REF : M22AL/UM/EN/004 8. RBC. TECHNOLOGY 8. 2).2).2) INS_H: HGB channel saturation. Page 82/109 Copyright© Orphee SA. run a concentrated cleaning (see section 9. if it persists. hyper segmented Neutrophils. .: Counting gap between resistive and optical WBC count. All Rights Reserved. 8. O_CL: Suspicion of Optical injector clog.5.The WBC flags appear when the % AND # limits are reached. run a concentrated cleaning (see section 9. TECHNOLOGY 8. IC: Presence of Immature Cells (from the mono or polynucleated cells line) Number of cells located of each side of the threshold: RL (Right Lymphocytes): Presence of atypical lymphocytes or basophils. NH (Neutrophils High): Presence of giant Neutrophils.8. HL (High Lymphocytes): Presence of basophils. run a concentrated cleaning (see section 9. eosinophils with few granulations or damaged eosinophils. INS_T: A temperature (enclosure. run a concentrated cleaning (see section 9.5. debris or resistant RBC N2 (Noise 2): Presence of platelet aggregate.1. band cells. These flags may appear if the blood was not stored in good conditions or if it was sampled too many times (more than 20 times). OPT. NL (Neutrophils Low): Presence of small Neutrophils (without granulations or few segmented).1. reagents or ambient) is out of range (see section 9.1. if it persists. if it persists.2). if it persists. erythroblast or small lymphocytes.5.2) INS_P: Pressure default (see section 9.3 Leukocytes Flags SCATTERGRAM FLAGS: NH NL IC N1 N2 HL RL All the followings flags’ levels are adjustable in the 20 types of blood (see section 3.4. band cells or hyper basophil Monocytes.1.2 Instrument Flags REF : M22AL/UM/EN/004 W_CL: Suspicion of WBC aperture clog. Number of cells in a zone: N1 (Noise 1): Presence of platelet aggregate. MYTHIC 22 AL .4). small Neutrophils (without granulations or few segmented). R_CL: Suspicion of RBC aperture clog.2). run a START UP cycle.5. 5.If one or more DIF parameters (LYC. MYTHIC 22 AL Copyright© Orphee SA. Page 83/109 . This flag appears when samples are run without START UP running. SU_ND: STARTUP Not Done.5. P2 = P to CP2: Presence of schizocytes. R2 = Abnormal quantity of macrocytes at the right side of CR2. TECHNOLOGY DIF parameters display rules: . 8. erythroblast or small lymphocytes at the left of CL1.5 Platelet Flags CP3-2 CP1 CP2 P CP3 P1 = 0 to CP1: Presence of abnormal quantity of debris or small cells. . 8. This flag is printed with each result. P3 = CP3 to CP3-2: Presence of microcytes. CL1 CL5 L1 = Presence of platelet aggregate. This flag is printed with each result. MON.Basophil result must be checked on smear if it is followed by a star (XXX *).4 CR1 Erythrocyte and HGB Flags CR2 R1 = Abnormal quantity of microcytes at the left side of CR1.7 STARTUP Flags SU_F: STARTUP Failed. All Rights Reserved. See section 6. 8. L5 = Presence of immature cells at the right of CL5. . this flag appears when no QC was run before the analysis of samples. HGB: * means bad measure of the HGB blank. See section 5. the sample must be checked on smear. This flag appears when samples are run after a bad START UP. This flag is printed with each result. This flag appears when the result of the QC run was out of the limits.6 QC Flags QC_F: QC Failed.REF : M22AL/UM/EN/004 8. WBC CURVE FLAGS: This curve is done by the WBC channel measurement and does not appear on the normal results screen.5. NEU.4. QC_ND: QC Not Done.5.The RBC and PLT flags appear when the % limit OR # limit is reached 8. The flags L1 and L5 complete the flags N2 and IC. This flag is printed with each result. EOS or BAS) are followed with a star (XXX *). 6 HYDRAULIC & MECHANIC DESCRIPTION The hydraulic part of the MYTHIC 22 AL is very simple and made of these modules : 1 . It is made with a manifold maintaining the reagent commutation valves and the counting bath block with their measurement block including the apertures. 2 . Each sample is identified with the barcode reader before the sampling.Optical manifold. The o-ring of the needle included in the cleaning system can also be removed without tool (see section 9. transfer.3.3/4/5). The racks are loaded on the guide rail by a loading screw then displaced by another screw (transfer screw).2). 6 .Optical bench.6. MYTHIC 22 AL .3. it is unloaded by the unloading motor.Syringes module. 8.2). 8.3. 8.Counting bath module.2 Sampling module This module (two patents) enables to pierce the cap of the sample tube with one needle only. It is assembled with a rotating rocker moving around a support which maintains the system to move the sampling needle up and down.1 Auto loader module This module (patented) enables to load.8. The speed mixing is 25 reversals per minute with a minimum of 20 reversals for a first mixing then 10 per minute. 4 .4 Syringes module This module (two patents) enables: To draw the sample To distribute the reagents To drain the baths To do the vacuum necessary for counting To push the waste to the waste container To push the WBC sample and the diluent sheath. All Rights Reserved. REF : M22AL/UM/EN/004 8. Page 84/109 Copyright© Orphee SA. TECHNOLOGY 8. Each rack is also identified by the barcode reader.1).6. 5 . mix and unload the racks.6. Ten racks of five tubes can be loaded. 8.Auto loader module. The system allows the rerun of the sample before the displacement to the next sample tube (see section 3. A very reliable system of rack-gear moves the rocker.6. The cleaning system of the sampling needle can be removed without tool (see section 9. It is made with a manifold maintaining the fluid commutation valves and with the syringes block including five syringes: The sampling syringe The lysis syringe The two waste and vacuum/pressure syringes And the diluent syringe.5 Optical manifold This manifold allows driving the different reagent towards the counting bath module or towards the optical bench. The maintenance of these parts is very easy to perform.3 Counting bath module This module allows to count the WBC and RBC/PLT and to measure the HGB. The modules are connected together by semi rigid tubing. The counting bath block assembly and these apertures can be removed without tool (see section 9. The loading can be done continually. The rail which maintains the rack can also rotate for mixing the blood inside the tubes.Sampling module. The blood is mixed by complete returning.4. 3 . to draw the sample and to perform the WBC and RBC/PLT dilutions. When all the samplings are done for a rack. into the flow cell. Single motor drives the five syringes. It maintains seven commutation valves.6. . allow to go to the first or the last line of a table. It is made of three parts: . a beam separation glass smear. Allows to delete the modification in progress in one box. The following buttons are common for the screens where entries are possible: Allows to leave the screen after modifications. MYTHIC 22 AL Copyright© Orphee SA.7. it is mandatory to do the action described in the window or in the table section 9. Allows to cancel all modifications done in one or several boxes.A button in grey ( ) instead of white ( )means that it is not available at this moment. a beam adjustment glass smear.An illumination module which contains the semi conductor light source. save or delete it. depends on the screen. allow to move on the right or on the left page by page or column by column.6. for example to select information. and lens.6.1 Common Functionalities located at the top of the screens are allows to come back to the previous display. send. .And the detection module which contains lens.7 SOFTWARE 8.A flow cell made of injected plastic in which the sample and the passive sheath flow away. Windows (prompts): Means an ERROR occurred. All Rights Reserved. it allows to open a window dedicated to perform an action. . Common buttons: These four keys always present: - allows to come back to the MENU display wherever you are in the arborescence. photodiodes and the amplifier boards for the two measurement axes. allows to check the status of the sampler. this prompt allows to save (press YES) or not (press NO) the modification. allow to move at the beginning or at the end of the table.REF : M22AL/UM/EN/004 8. TECHNOLOGY This very important part (two patents) allows measurement of the leucocytes sub population. INFORMATION window: no action required. 8. to print. Once a modification is done. a prompt appears to request a confirmation. Page 85/109 . WARNING: You have to confirm or not the action described in the window. allow to change for the previous or next page.6 Optical bench 8. 2 Menu tree REF : M22AL/UM/EN/004 Page 86/109 Copyright© Orphee SA. MYTHIC 22 AL .7. TECHNOLOGY 8.8. All Rights Reserved. Increase the frequency of the cleaning of the MYTHIC 22 AL in case of analyzes of pathological samples or if there are too many flags and too often. After opening any doors or dismantle any parts.1.1.2 .6).Concentrated cleaning: see the following section 9.Barcode cleaning: see section 9.1. MAINTENANCE Reagents level Start Up Automatic cleaning Concentrate cleaning Shut down or concentrate cleaning Cover cleaning Piston greasing In line filter cleaning Barcode cleaning Needle o-ring replacement Syringes o-ring replacement Motor screw greasing DAILY User Tech WEEKLY User Tech QUARTERALY ( ~11250 cycles) User Tech HALF A YEAR ( ~22500 cycles) User Tech ANNUALLY ( ~45000cycles) User Tech X X X X X X X X X X X X X X X X X X MAINTENANCE TO BE DONE BY THE USER (yellow boxes): .In line filter cleaning: see section 9. Page 87/109 .Start up: see section 5.3 .1.1 MAINTENANCE 9. to wear rubber gloves and wash hands with a disinfectant after completion of work. . for performing a cleaning or a repairing.Automatic Cleaning: The cleaning is automatically performed by the MYTHIC 22 AL following the set up defined by the user (see section 3. (The standard value is 80). please proportionally increase the number of maintenances.3 . SERVICE The quality of the results and the reliability of the MYTHIC 22 AL are directly linked to the strict respect of the maintenance hereafter described.4.REF : M22AL/UM/EN/004 9. All Rights Reserved. For more.2 MYTHIC 22 AL Copyright© Orphee SA.Piston greasing: see section 9.Reagents level control: see section 5.1 Maintenance table NOTA: This table is made for an average number of 150 samples per day.Shut down or concentrate cleaning: see section 5.Needle o-ring replacement: see section 9.3.2 .11 . SERVICE 9. it is mandatory to have been adequately trained. .1.4 . To perform the maintenance and the repair described in this section.Cover cleaning: Clean the cover above and around the sampling needle with a wet paper with a disinfectant to eliminate the blood trace. 9.5 . take attention with all metal sheets which can injure your fingers. 5). SERVICE 9.Wait for the prompt. . All Rights Reserved. . Prepare a Sodium Hypochlorite solution at 12° in chloride (diluted 4 times with distilled water if sodium hypochlorite is concentrated at 48° in chloride or three times with 36°).1. then lift it to remove. .Open the door on the right side by unscrewing the two quarter turn screws with the key provided in the kit. MYTHIC 22 AL . .2 Concentrate cleaning REF : M22AL/UM/EN/004 This cleaning is necessary once a week to clean the WBC bath or when MYTHIC 22 AL is in permanent rejection for at least one measured parameter or permanent clog flag (see section 8. . Page 88/109 Copyright© Orphee SA.9.Open completely the door.Press .1.Return to the main menu by pressing . then: .Then press . After 2 min. All Rights Reserved.Put bleach in a container .MYTHIC 22 AL performs a maintenance cycle of the apertures and the flow cell. Page 89/109 . . .Press the button in the window located in the middle of the screen. SERVICE Wear rubber gloves and wash hands with a disinfectant after completion of work.Clean the top of the bath (some traces of dried blood can remain) with the tip until the complete removing of the durst. Wear rubber gloves and wash hands with a disinfectant after completion of work. MYTHIC 22 AL Copyright© Orphee SA. . . otherwise the counting electrode could be damaged and the results altered.Put 3 ml of sodium hypochlorite solution in each counting chamber. IMPORTANT NOTICE Never enter the tip inside the bottom of the bath. Operator can perform an analytic cycle. MYTHIC 22 AL rinses all of the elements.Then introduce the tip to wet it . followed with a standby mode during 2 min.REF : M22AL/UM/EN/004 9. .Close the door. . SERVICE 9. press from the MAIN MENU.9. with a . . MYTHIC 22 AL . Page 90/109 Copyright© Orphee SA.The other pistons can be turned with fingers. there is a risk to pinch their fingers between pistons and the syringe body.1. .Keep on putting a thin film of grease around each piston. . All Rights Reserved. Operators must be trained and should know that due to moving parts.3). .Put a small nut of grease on a finger.Open the door on the right side and remove the unloading table (see section 1.1.Turn the two big pistons (waste pistons) with the help of the key provided in the installation kit. .3 Piston greasing REF : M22AL/UM/EN/004 - To have access to the hydraulic cycle. and then press to put the piston of the syringe module in the greasing position. Wear rubber gloves and wash hands disinfectant after completion of work.Put a THIN FILM of grease around each piston. Exchange or clean the filter following the maintenance table (see section 9. All Rights Reserved. .5. 9.The filter is dismountable and cleanable. switch off the AL and call Orphee representative.1. close it. .Open the front door only when the light is green 5.Always open the filter after the disconnection of the luer to avoid losing the o-ring. . . The barcode reader is a laser CLASS II. never dismantles the cover. in case of problem call Orphee representative. . SERVICE 9. MYTHIC 22 AL Copyright© Orphee SA.1.2).2).Reassemble with the two parts and screw the two parts completely.REF : M22AL/UM/EN/004 9.Clean the mirror of the barcode reader with soft paper and a glass cleaner. .The in line filter allows to eliminate the small pieces of rubber cap which could be generated in case of multiple sampling of the same sample or if the rubber cap quality is poor.5 Barcode cleaning .Unscrew the luer part of the filter from the part remaining fixed.Unscrew the two parts of the filter. and clean the part with the grid under water (the grid is fixed with the part). remove the o-ring. Wear rubber gloves and wash hands with a disinfectant after completion of work. Page 91/109 . the MYTHIC 22 AL will stop with a pressure alarm “NEEDLE RINSING DEFAULT” (see section 9.1. If the o-ring is missing or if the filter is not completely screwed.6.8) (see section Be careful with laser light of the barcode reader.4 In line filter cleaning .1) or when the message “NEEDLE RINSING DEFAULT” appears (see section 9.Disconnect the luer connector and let the other tubing connected on the filter. if the red light is present during the opening of the door.5. . MYTHIC 22 AL .3. press from the MAIN MENU.To have access to this cycle.1 to 9. press the MAIN MENU.The function of each button is described in the sections hereafter (9. SERVICE 9. . then press from NOTA: TECHNICIAN is only available to the Orphee’s service people. To fill the counting baths.3 TROUBLESHOOTING SCREEN .2 CLEANING CYCLES REF : M22AL/UM/EN/004 . in the flow cell. the flow cell and the waste syringes. To perform a cleaning of the aperture blocks and the flow cell with the cleaner.5): Page 92/109 Copyright© Orphee SA. in the aperture blocks. then press: To drain the counting baths.To have access to the hydraulic cycles.9. the flow cell and the waste syringes.3. To perform a back flush To perform a back flush 9. All Rights Reserved. then press again to switch it off. MYTHIC 22 AL Copyright© Orphee SA.At each pressing.REF : M22AL/UM/EN/004 9.This screen allows checking if the different sensors are available in case of problem.3.2 Check sensors . check the function. . Page 93/109 . SERVICE 9. if nothing is heard.The four buttons located at the bottom of the screen allow checking: the HB led. call an Orphee’s representative. press the button. For testing.3.3.For testing the valve. press the dedicated button to switch the valve on.Range of trigger temperature: Ambient: 17°C <--> 35°C Enclosure: 32°C <--> 40°C Reagents: 34°C <--> 45°C . the aperture current and the pump. All Rights Reserved.3 Check valves . NOTA: To understand the function of each sensor we recommend to follow an Orphee’s training. 9. then press again the button. a click (noise) can be heard. 9. . the optical led.1 Sampler NOTA: To understand the function of each button we recommend to follow an Orphee’s training. In case of problem. immediately press .4 Check motors fluidics REF : M22AL/UM/EN/004 Each motor of the fluidics part is tested during a short cycle. the associated prompts will be displayed.To print a part of or all the errors press . 9.4 REPAIRING After opening any doors or dismantle any parts.4.After having identified the problem (see section 9. take attention with all metal sheets which can injure your fingers. as well as the code and the origin of this error.3. SERVICE 9.5 Log errors . for performing a cleaning or a repairing. . it is necessary to perform a system initialization by pressing or accede to this cycle by pressing from the MAIN MENU. To print or save (on an USB key) the errors. .3.This screen allows visualizing the date and timing when an error has occurred. 9. select ALL for all the pages (the number appears at the right) or select ERR.5). 9.1 Emergency stop In case of mechanical or hydraulic problem. the MYTHIC 22 AL will make an emergency stop.9. Page 94/109 Copyright© Orphee SA. If one or several motors are in default. All Rights Reserved. then the starting number and the ending number. MYTHIC 22 AL . call your Orphee’s representative. .The needle is in front of the counting chambers . All Rights Reserved. unloads the racks which remain in the sampler. SERVICE .2 Needle or o-ring replacement Wear rubber gloves and wash hands with a disinfectant after completion of work.To perform the system init press . MYTHIC 22 AL Copyright© Orphee SA.REF : M22AL/UM/EN/004 9.First remove the top of the needle from the clip.This cycle allows reinitializing all the motors. and then lift it to remove. The replacement of the o-ring is MANDATORY for each disassembling of the needle.Open completely the door. clean and rinse all the fluidics part. Page 95/109 . leave the needle free in front of the clip (do not pull a lot the upper needle). .4.After this initialization. 9. the work may continue. . .Open the door on the right side by unscrewing the two quarter turn screws with the key provided in the kit. Remove the tubing fixed at the end of the needle only if you want to change the needle.Pull the needle and the rinsing head system towards outside. Page 96/109 Copyright© Orphee SA. SERVICE REF : M22AL/UM/EN/004 . while slightly lowering the clip to the bottom. MYTHIC 22 AL .9. . All Rights Reserved.Leave the tubing connected if you only change the o-ring. . .Remove the sampling module. Raise up together the serrated roller. Page 97/109 . . Only grease and lightly the o-ring between your fingers. the grease could block the grooves and create diluent leak and the results would be altered. Place the seal on the needle gently in order not to wound it. REASSEMBLY PROCEDURE: To reassemble the unit. . MYTHIC 22 AL Copyright© Orphee SA. Do not grease the needle after removing. the grease could block the grooves and create diluent leak and the results would be altered. SERVICE .REF : M22AL/UM/EN/004 9. carry out the various operations in the opposite direction.Remove the o-ring. If the needle is greased. All Rights Reserved. If the needle is greased.Unscrew the serrated roller which maintains the seal and the needle. .Replace the needle and/or the o-ring. the needle and the o-ring from the rinsing head. pull the clip 1 while pushing the top from the counting bath towards the inside of the machine 2.To remove the counting bath module.3 Baths dismantling REF : M22AL/UM/EN/004 This procedure must be carried out to replace the bath seals on the manifold or the aperture seals. MYTHIC 22 AL .From the MAIN MENU.The WBC and RBC bath will be emptied. All Rights Reserved.4. 2 1 Page 98/109 Copyright© Orphee SA. press .9.Then press . . . Wear rubber gloves and wash hands with a disinfectant after completion of work. SERVICE 9. . . Next.REF : M22AL/UM/EN/004 9.Then. SERVICE .Remove the tubing fixed on the plastic fitting located under the stainless tube from WBC counting block. Page 99/109 . . MYTHIC 22 AL Copyright© Orphee SA. located on the right side of the counting module. Leave the sheath on the tubing. All Rights Reserved. remove the tubing fixed on the RBC counting head. raise the counting module. . Leave the sheath on the tubing. upwards. 4 Baths o-ring replacement Wear rubber gloves and wash hands with a disinfectant after completion of work. Place the seal on the counting bath gently in order not to wound it.4. Do not forget to put the sheaths back on the tubing.The counting bath module can now be handled to carry out the required operations of replacement. . MYTHIC 22 AL . SERVICE REF : M22AL/UM/EN/004 . REASSEMBLY PROCEDURE : To reassemble the unit. Page 100/109 Copyright© Orphee SA.Before performing the operation. All Rights Reserved.4. . .9.3). REASSEMBLY PROCEDURE : To reassemble the unit.Replace the o-ring and/or the complete bath block.Remove all connectors. carry out the various operations in the opposite direction. carry out the various operations in the opposite direction. 9. drain the baths and dismantle the counting bath block (see section 9. . Place the seal on the aperture block gently in order not to wound it.Remove the o-ring and replace it by a new one or replace the whole part. Do not grease the aperture o-ring. MYTHIC 22 AL Copyright© Orphee SA.4. drain the baths and dismantle the counting bath block (see section 9. unscrew the screw and remove the connection. .Before performing the operation. SERVICE 9.3). .4. . NOTA: This operation can be performed without dismantling the complete bath block. . All Rights Reserved.Remove the tubing from the blocks to be replaced. NOTA: The WBC aperture block is marked with a figure 8 on the ear and with a figure 5 for the RBC. REASSEMBLY PROCEDURE : To reassemble the unit.With the tool provided in the maintenance kit.5 Aperture block replacement Wear rubber gloves and wash hands with a disinfectant after completion of work.REF : M22AL/UM/EN/004 9. carry out the various operations in the opposite direction.Unscrew the aperture block a quarter of turn. Page 101/109 . Check the level bubble flow in the WBC bath during the run cycle. MYTHIC 22 AL . Rejection * Check the results on blood smear. * Perform a new Start Up cycle. Check the reagent and enclosure temperature. Check the preampli connection wires. Check the reagent and enclosure temperature. HGB & WBC Perform a Back flush Cycle and then a Bleach cycle if unsuccessful. Check the reagent and enclosure temperature. 16 & 17. Check if the diluent container is at the same level as the analyzer. Check the bubble flow level in the RBC bath during the run cycle. bad stability & WBC Check the right lysis tubing connection to the WBC bath. No result Check the led light on Bad stability Check if no bubble in the lysis tubing. if a problem is not solved. Check the valve No 9. Rejection --Close the door. Perform a new Start Up cycle. No result or No HGB Check the lysis level.5 TROUBLESHOOTING OCCURENCES REF : M22AL/UM/EN/004 In any case. No result No HCT & PLT Check the bath wires. Check the right lysis tubing connection to the WBC bath. HGB OK Check the bath wires. Bad stability HCT & PLT Perform a Back flush and a Cleaning Cycle and then a Bleach cycle if unsuccessful. Perform a Cleaning Cycle and then a Bleach cycle if unsuccessful.5. SERVICE 9. 9. Check the bubble flow level in the WBC bath during the run cycle.9.1 PARAMETERS WBC Analytical problems PROBLEMS No result 5 DIFF RBC HGB ALL CONDITIONS SOLUTIONS No HGB Check the lysis level. call your Orphee’s representative. Change the aperture block if unsuccessful. Perform a Cleaning Cycle and then a Bleach cycle if unsuccessful. Flag INS_H Close the door. 13. OK Check the valves No 12. Check the bubble flow level in the WBC bath during the first dilution. Page 102/109 Copyright© Orphee SA. Bad stability Perform a Back flush and a Cleaning Cycle and then a Bleach cycle if unsuccessful. Bad results Check the diluent level and if the tubing is pinched. All Rights Reserved. Check the valve No 9. REF : M22AL/UM/EN/004 9. call your Orphee’s representative.3).1. MYTHIC 22 AL Copyright© Orphee SA. also check the level of the reagents.3) and check the tubing connection of the fluidics.DRAIN BATH DEFAULT: check the tubing connection of the fluidics.1. see section 9.NEEDLE RISING DEFAULT: check the in line filter locking (see section 9.4) and the pump operation.2 ORIGIN ANALYZER Other problems PROBLEMS SOLUTIONS Diluent leaks around the needle Check the rinsing needle block (presence of clots) and clean it if during the run cycle necessary. Message: CYCLE: PRESSURE Cases of occurrence (each case has his dedicated prompt): DEFAULT or Flag INS_P NOTA: For all these occurrences.SYRINGE VACUUM: perform a piston greasing (see section 9.3) and check the tubing connection of the fluidics.3. OF RANGE or flag INS_T Trigger temperature values: Ambient: 17°C <--> 35°C Enclosure: 32°C <--> 40°C Reagents: 34°C <--> 45°C Stop of the analysis Proceed as stated hereafter for all prompt starting with CYCLE. Page 103/109 . SERVICE 9.VACUUM COUNTING DEFAULT: perform a piston greasing (see section 9.2 No starting Check the power supply connection wires No display Check the flat cable. .2. .5. Message : TEMPERATURE OUT Check the origin of the problem of temperature in section 9.4. . .1. Wait the complete stop of the sampler (the red LED becomes green ) then Perform a SYSTEM INIT (MENU/SERVICE) if the problem remains. Clean the needle by removing the grease in the grooves. All Rights Reserved. ID and/or PID typing impossible ID and/or PID are mandatory (see section 3.4. 3) Check the paper level.2) If the problem remains. PRINTER No printing Bad printing Check if the printer is selected (see section 3. then open the front door and clean the mirror (see section 9. Check the electrical connection.8) and check if the mixer can move easy from top to low position (nothing as tube.1. should breach the movement) then close the door and perform a SYSTEM INIT (MENU/SERVICE) if the problem remains. Page 104/109 Copyright© Orphee SA.6. open the front door (see section 5. if necessary.6. check the quality of the blood sampling label and change it. Mixer blocked Proceed as stated hereafter for all prompt starting with MIXER: Perform a SYSTEM INIT (MENU/SERVICE) if the problem persists. SERVICE SAMPLER No Barcode reading Non loading of a rack REF : M22AL/UM/EN/004 Wait for the end of the in progress cycle. call your Orphee’s representative. call your Orphee’s representative. All Rights Reserved. MYTHIC 22 AL . Proceed as stated hereafter for all prompt starting with EJECTOR: Remove all the racks present on the unloading part then run a SYSTEM INIT (MENU/SERVICE) if the problem remains. Check the ink ribbon or the ink cartridge. Rack blocked Proceed as hereafter for all prompt starting with TRANSFER: Perform a SYSTEM INIT (MENU/SERVICE) if the problem remain call your Orphee representative. read the printer’s operator’s manual. Rack is ejected directly without The barcode of the rack is missing or altered.6. Rack blocked during the ejection.5) Proceed as stated hereafter for all prompt starting with LOADER: Check if the rack is in the good loading position and if the round label and the barcode label are present and clean (see section 5.9. call your Orphee’s representative. NOTA In any case of problem generated by the printer. please perform a SYSTEM INIT. Internal database as been restored after detecting incoherence. INIT PRINTER INTERN: COUNT ERROR ACTION Re-start the Mythic. HARDWARE: HEAT ENCLOSURE STOPPED. BACKUP: QC HISTORY IS FULL BACKUP: REPAIR SECTOR DONE.6 TROUBLESHOOTING MESSAGE This section allows knowing what to do when a troubleshooting message appears on the screen. PLEASE WAIT. Enter an ID and/or PID and SID. A bad Result storage occurred. SYSTEM INIT NOT DONE CYCLE: PUMP COMMAND FAILED. CYCLE STOPPED BY USER CYCLE: BUSY CYCLE: CMD VALVE FAILED CYCLE: EMERGENCY STOP CYCLE: FLUIDIC DOOR OPENED CYCLE: HGB CHANNEL SATURATION. BACKUP: LAST QC RESTORED. Page 105/109 . Perform a SYSTEM INIT. Perform a CLEANING. Replace the bottle and perform a prime Cleaner. BACKUP: PARTIAL QC RES. BACKUP: PARTIAL NUM DELETED. BACKUP: NO MEMORY AVAILABLE FOR STORAGE BACKUP: PARTIAL CALI. SERVICE 9. PLEASE DELETE RESULTS. You have to delete results. Change the valve Replace the container and perform a prime Diluent Check the hardware connection on ALL Board Check the hardware connection on FSC Board Check if your temperature fan is running. File has been restored to previous state Memory full. HARDWARE: HEAT REAGENT FAILED. Check the pump connection. RES.C BOARD ID FAILED. BACKUP: LAST RESULTS RESTORED. A bad Result storage occurred. Switch on the printer or invalidate the printings. call an Orphee’s representative. BACKUP: LAST SETUP RESTORED. Perform an initialization or a SYSTEM INIT. Wait before performing a cycle. Hardware failure on memory Indicate that your SETUP has been released.S. Re-start the Mythic.L BOARD ID FAILED. SID ALWAYS MANDATORY. A bad Result storage occurred. Re-start the Mythic. PLEASE RUN STARTUP. Re-start the Mythic. next result will not be saved. DELETED. MESSAGE BACKUP : FOLDER NOT FOUND BACKUP: BAD FOLDER DUPLICATION BACKUP: CALIBRATION HISTORY IS FULL BACKUP: FAIL TO SAVE RESULT ONTO THE EXTERNAL STORAGE DEVICE. Try again. Rebuild cycles with good options. Check your enclosure sensor. All Rights Reserved. Re-start the Mythic. If the problem remains contact your Orphee’s representative. Delete the repeatability results. If the problem still occurs. BACKUP: REPEATABILITY HISTORY IS FULL BACKUP: SECTOR FAILED. DELETED. HARDWARE: HEAT REAGENT STOPPED. Emergency stop. HARDWARE: HEAT ENCLOSURE FAILED. Re-start the Mythic.REF : M22AL/UM/EN/004 9. Check if the USB thumb drive is connected to the analyzer. Wait for the system to reach its temperature. File has been restored to previous state Indicate that your SETUP has been restored Delete results Delete the stored results. THE INTERNAL MEMORY IS USED. HARDWARE: F. DELETED.L. ID AND/OR PID MANDATORY (CHECK SETUP). Communication errors re-try. BACKUP: FILE SYSTEM FAILED. RES. MYTHIC 22 AL Copyright© Orphee SA. call an Orphee’s representative. Check your reagent sensor. if the problem occurs. HARDWARE: FAN FAILED. BACKUP: PARTIAL REPET. BACKUP: SYSTEM ERROR CLEAN NOT DONE CLEANER ALMOST EMPTY COM: BAD CYCLE MODULE COM: CRC CONTROL ERROR COM: SIZE ERROR. Delete the Q. May occur by leak of reagent or check tubing in the fluidics. BACKUP: SETUP UPDATED WITH DEFAULT VALUES. Run SYSTEM INIT. Run Startup Cycle. HARDWARE: SYSTEM ERROR HEATING IN PROGRESS. Call an Orphee representative.C. CYCLE: INIT NOT DONE CYCLE: PRESSURE DEFAULT CYCLE: VALVE “X” FAILED DILUENT ALMOST EMPTY HARDWARE: A. BACKUP: MEMORY IS ALMOST FULL. A bad Result storage occurred. Call an Orphee’s representative. BACKUP: LAST RESULT SAVED. results of the ongoing lot. Delete the calibration results. Close the Fluidic door. Change the valve Perform a SYSTEM INIT. System is resetting after the version is released. Perform a clean cycle. MYTHIC 22 AL . Perform a start up cycle. SETUP: MODIFICATION NOT ALLOWED. Nothing to do Re-start the Mythic. Re-start the Mythic. The instrument is ready to work. Page 106/109 Copyright© Orphee SA. re-start the Mythic. Nothing to do Re-start the Mythic. Switch on the printer or invalidate the printings. All Rights Reserved. Switch on the printer or invalidate the printings. START UP CYCLE NOT DONE STARTUP CYCLE FAILED SYSTEM LOCKED HEATING FAILED SYSTEM: DOWNLOADING NEW VERSION. Perform a SYSTEM INIT Re-start the Mythic. PLEASE WAIT SYSTEM: EEPROM COM ERROR ACTION REF : M22AL/UM/EN/004 Re-start the Mythic. ACTION CANCELLED. Re-start the Mythic. Switch on the printer or invalidate the printings. Nothing to do Perform a SYSTEM INIT Perform a SYSTEM INIT Re-start the Mythic. Modify the value Select the right driver compatible with the Mythic. PLEASE DELETE FILES. Perform a SYSTEM INIT. Perform a pistons greasing. PRINTER ERROR PRINTER IS BUSY PRINTER IS OFF PRINTER: NO PAPER RINSE NOT DONE RS232: ACK ERROR RS232: INTERNAL ERROR RS232: SYNCHRO ERROR RS232: TIME OUT RUNNING AUTO CLEANING SET TEMPERATURE REACHED. You have to be logged with the good access code. Add some paper. Re-start the Mythic. Re-start the Mythic. NO PRINTER RESPONSE NO PRINTER SELECTED NO PRINTER SELECTED NUMBER MAX. Switch on the printer or invalidate the printings. Delete data on the selected directory. OF FILES REACHED. Nothing to do Perform a SYSTEM INIT Check your analyzer configuration Check your analyzer configuration Switch on the printer or invalidate the printings. Re-start the Mythic. Wait before performing a cycle. Re-start the Mythic. SERVICE MESSAGE INTERN: MEMORY CORRUPTED INTERN: NO MEMORY AVAILABLE INTERN: RESULT AREA IS LOCKED INVALID DATA FORMAT. Replace the bottle and perform a prime Lysis Perform a SYSTEM INIT Perform a SYSTEM INIT Perform a SYSTEM INIT Re-start the Mythic. Press OK. FAILED. FAILED NETWARE: CLIENT INIT. Nothing to do Perform a SYSTEM INIT Perform a SYSTEM INIT Re-start the Mythic. Call an Orphee’s representative. LOT ALREADY EXISTS. Perform a new start up cycle.9. OUT OF RANGE PRINTER DRIVER UPDATE FAILED. Nothing to do Perform a SYSTEM INIT Perform a SYSTEM INIT Re-start the Mythic. If persisting. Check the data format Select another lot. THE CHOSEN DRIVER IS NOT COMPATIBLE WITH THE MYTHIC SYSTEM. LYSE ALMOST EMPTY MECA: HOME NEEDLE NOT FOUND MECA: HOME ROCKER NOT FOUND MECA: HOME SYRINGE NOT FOUND MECA: MOTOR NEEDLE BUSY MECA: MOTOR NEEDLE GAP MECA: MOTOR ROCKER BUSY MECA: MOTOR ROCKER GAP MECA: MOTOR SYRINGE BUSY MECA: MOTOR SYRINGE GAP MECA: NEEDLE NOT IN TOP POSITION LOADER: MOTOR HOME NOT FOUND LOADER: MOTOR BUZY LOADER: ERR MOTOR GAP LOADER: ERR MOTOR STOP TRANSFER: MOTOR HOME NOT FOUND TRANSFER: MOTOR BUZY TRANSFER: ERR MOTOR GAP TRANSFER: ERR MOTOR STOP MIXER: MOTOR HOME NOT FOUND MIXER: MOTOR BUZY MIXER: ERR MOTOR GAP MIXER: ERR MOTOR STOP EJECTOR: MOTOR HOME NOT FOUND EJECTOR: MOTOR BUZY EJECTOR: ERR MOTOR GAP EJECTOR: ERR MOTOR STOP NETWARE: SERVER INIT. Switch on the printer or invalidate the printings. The USB thumdrive has an incompatible tree structure for the analyzer. try another one. try another one. USB: THUMB DRIVE IS FULL. The USB thumdrive has an incompatible tree structure for the analyzer. The USB thumdrive has an incompatible tree structure for the analyzer. The USB thumdrive has an incompatible tree structure for the analyzer. VERSION RELEASE FAILED. try another one. Select the correct version. Re-start the Mythic. Connect an USB thumdrive. USB: EMPTY FILE USB: THUMB DRIVE I/O ERROR. try another one. try another one. Replace the bottle and perform a prime Cleaner Replace the container and perform a prime Diluent Replace the bottle and perform a prime Lysis The USB thumdrive has an incompatible tree structure for the analyzer. The USB thumdrive has an incompatible tree structure for the analyzer. The USB thumdrive has an incompatible tree structure for the analyzer. USB: TOO MANY FILES OPENED. Select the right version. USB: THUMB DRIVE IS NOT PRESENT. No memory available in USB for storage. VERSION RELEASE FAILED. try another one. try another one. try another one. USB: EMPTY FILE USB: THUMB DRIVE I/O ERROR. try another one. The USB thumdrive has an incompatible tree structure for the analyzer. Page 107/109 . Replace the waste container MYTHIC 22 AL Copyright© Orphee SA. Replace the waste container The USB thumdrive has an incompatible tree structure for the analyzer. try another one. Connect an USB thumdrive. USB: UNABLE TO CREATE DIRECTORY. try another one. THE DILUENT USED IS OUT OF DATE. try another one. USB: DIRECTORY IS NOT EMPTY. The USB thumdrive has an incompatible tree structure for the analyzer. USB: UNABLE TO OPEN FILE USB: WRITE PROTECTED FILE. Room temperature out of range (<18 or >34°C). No memory available in USB for storage. USB: DIRECTORY IS NOT EMPTY. try another one. The USB thumdrive has an incompatible tree structure for the analyzer. WASTE ALMOST FULL USB: DIRECTORY DOES NOT EXIST. You have to delete some data to work. USB: THUMB DRIVE IS FULL. The USB thumdrive has an incompatible tree structure for the analyzer. USB: UNABLE TO CREATE DIRECTORY. USB: THUMB DRIVE IS NOT PRESENT. The USB thumdrive has an incompatible tree structure for the analyzer. WASTE ALMOST FULL ACTION 9. USB: DIRECTORY DOES NOT EXIST. try another one. try another one. try another one. USB: UNABLE TO OPEN FILE USB: WRITE PROTECTED FILE. The USB thumdrive has an incompatible tree structure for the analyzer. The USB thumdrive has an incompatible tree structure for the analyzer. USB: UNABLE TO OPEN DIRECTORY. The USB thumdrive has an incompatible tree structure for the analyzer. THE CHOSEN RELEASE IS NOT COMPATIBLE WITH THE MYTHIC 22 AL SYSTEM. try another one. THE CHOSEN RELEASE IS NOT COMPATIBLE WITH THE MYTHIC 22 SYSTEM. All Rights Reserved. SERVICE Re-start the Mythic. USB: UNABLE TO OPEN DIRECTORY. THE LYSE USED IS OUT OF DATE. USB: TOO MANY FILES OPENED. The USB thumdrive has an incompatible tree structure for the analyzer.REF : M22AL/UM/EN/004 MESSAGE SYSTEM: FATAL ERROR SYSTEM: INTERNAL TIME OUT TEMPERATURE OUT OF RANGE THE CLEANER USED IS OUT OF DATE. You have to delete some data to work. try another one. The USB thumdrive has an incompatible tree structure for the analyzer. All Rights Reserved. MYTHIC 22 AL . SERVICE 9.7 HYDRAULIC DIAGRAM REF : M22AL/UM/EN/004 Page 108/109 Copyright© Orphee SA.9.